Medical Economics in Interventional Cardiology


Key Points

  • There are three forms of full economic evaluations that do not assume equivalence of health outcome: cost-effectiveness analysis (CEA), cost-utility analysis (CUA), and cost-benefit analysis (CBA).

  • Both CEA and CUA are widely used to decide whether a medical intervention is economically attractive, whereas CBA is used much less.

  • CEA and CUA assess the incremental costs for a therapy or strategy to produce an incremental unit of health benefit; health benefits are traditionally assessed as either the number of added life-years (LYs) or quality-adjusted life-years (QALYs).

  • Economic assessment is usually assessed over a time horizon. Typically, a lifetime horizon is used and that requires assessing both the future costs and health benefits. Future costs and health gain are commonly weighted in relation to the time at which they occur, and usually future costs and health effects receive less weight than present ones.

  • Medical cost studies generally fall into one of three categories: cost-effectiveness simulations using Markov models, observational studies, and randomized controlled trials (RCTs).

  • Although from a scientific standpoint cost-effectiveness acceptability curves should be used when assessing whether a treatment is cost effective, a requirement for threshold usually arises when policy makers seek a benchmark to compare different treatments and judge different studies.

Introduction

Health care costs are increasing steadily in the developed world, due in part to the development of new and more expensive medical technologies and treatments. The field of interventional cardiology has undergone tremendous changes over the past 10 years, with expansion in diagnostic and therapeutic tools used in coronary interventions, as well as the introduction of new catheter-based interventions for noncoronary cardiac conditions. Although percutaneous coronary intervention (PCI) remains among the most common major medical procedures in the United States, data suggest that the volume of PCI is declining or at least that there will be minimal growth in the near future. On the other hand, there is significant expansion in the volume of noncoronary interventions, including peripheral arterial and structural heart disease interventions, with a concomitant increase in the involvement of interventional cardiologists in these procedures.

The changes in the field, the aging population, and the limitations on resources and reimbursements the Patient Protection and Affordable Care Act have engendered make understanding basic concepts on medical economics a necessity. The goal of this chapter is to provide an overview of the basic concepts of medical economics and show the available evidence of economics in different aspects of interventional cardiology.

Medical Economics: Concepts and Methods

Basic Concepts/Terminology

A fundamental concept of economics is that resources are limited and can never satisfy all societal wants, and therefore when resources are used for health care, they are lost for other potential uses, such as education, infrastructure, or the environment. Thus we should think of cost not merely as money required to provide a particular good or service but rather as the opportunity cost, where it represents the consumption of the society’s resources required to produce that good or service, that could have been used for other purposes.

Because opportunity cost remains more a fundamental concept rather than a real measurement tool, other metrics for cost are necessary. The typical accounting price that is used in the regular market, which adds a reasonable amount of profit to the cost of production, is not clearly applicable in the U.S. medical field, due to cost shifting of many other expenses (e.g., bad debts, rejected payment by third parties, fee for services including employee salaries, cost of maintenance, and expansion of services). The addition of these cost-shifting fees distorts the relationship between U.S. medical charges and medical resource consumption. Therefore U.S. medical charges should not be used as a surrogate for medical costs in research and policy evaluations.

Other cost concepts used in medical economics include average cost, marginal cost, incremental cost, induced cost, and indirect cost. Average cost is overall cost per unit (i.e., the total costs divided by the total number of units of production). Marginal cost is the cost of producing one additional (or one less) unit of product, such as PCI or coronary bypass surgery. This concept excludes costs that do not vary as a direct function of production (termed fixed costs), such as the cost of the interventional laboratory or operating room facilities. Incremental cost is defined as the extra costs associated with an expansion in activity of a given service. Incremental cost is particularly useful in focusing on costs of shifting groups of patients from one diagnostic or therapeutic strategy to another and is essential in economic evaluations. For example, when a hospital is starting a transcatheter aortic valve replacement (TAVR) program, the incremental cost will adjust for the cost of hiring specialists who perform this procedure or training an existing interventional cardiologist, hiring a TAVR coordinator, training the catheterization lab staff about the procedure, and the cost of any new equipment and/or adjustment to the existing catheterization lab or operating room. Induced cost (or savings) is the cost of the tests or therapies added or averted as a consequence of some initial management decision, resource use, or both. For example, interventions that may cause more complications will increase (induce) use of resources, whereas an intervention that decreases complications or resource use may reduce (save) cost.

Medical Economics Terminology

Overall, economic evaluations provide vital information to decision makers on both the inputs and outcomes of a health or medical intervention compared with available alternatives. These types of analyses build on the results of clinical effectiveness studies but go beyond them to include a broader view of clinical, humanistic, and/or economic outcomes. Clinical outcomes are medical events that are considered meaningful by medical professionals. Humanistic outcomes include a broad array of intangible personal attributes, typically self-reported by patients, such as quality of life and even spiritual well-being. Economic outcomes represent the consumption and production of resources and their monetary value from the perspective of a decision maker. A full economic evaluation is a study that provides a comparison of one or more interventions/approaches of interest to a defined standard of care, especially the cost of each intervention/approach in relation to the effects (or benefits or returns) of each. Comparing only investment costs between interventions or approaches is considered a partial economic evaluation.

Cost Measurement

A thorough economic evaluation should completely account for all relevant costs. Such an evaluation does not include only the cost of the new treatment or test but also accounts for the costs of concomitant therapy, the costs of treating any complications, and the costs of subsequent events. For example, a new treatment for acute coronary syndrome might increase bleeding but reduce stent thrombosis and/or recurrent myocardial infarction (MI) and therefore the risk and cost of readmission. Therefore a fair evaluation would account for the extra cost of increase bleeding, as well as the potential cost savings of recurrent MI.

The time frame for the economic evaluation needs to be long enough to encompass all costs resulting from a particular intervention, because subsequent and long-term clinical complications may be decreased or increased by a treatment or test. Although some therapies may pay for themselves with immediate savings, others may have higher initial costs but later significant savings. Therefore it is crucial for every economic evaluation to have sufficient scope to account for all relevant costs, including both early and late adverse events. As costs may accrue over a lifetime, a lifetime time horizon will be the most inclusive. However, this may not always be feasible.

Evaluation of Procedure and Hospital Cost

Evaluation of the true cost of a specific procedure and the associated hospital stay is a very challenging process. In practice, obtaining the detailed data about individual resources being consumed for an intervention and adding up these costs to perform marginal or incremental cost analysis (the bottom-up approach) are difficult and often impractical. Performing a true bottom-up cost analysis (microcosting analysis) is a complex, time-consuming process that requires identification of all the inputs into a health care service and the assignment of an appropriate cost to each. Furthermore, even if this process was achievable for simple treatments, it becomes more complex when considering complex interventional procedures such as a PCI and very complicated when accounting for the entire hospital stay from admission to discharge. Therefore most U.S. cost studies start with an aggregated measure of costs, such as can be obtained from hospital or physician bills (a top-down analysis).

To overcome this complexity, cost data in the United States are obtained mainly by one of two approaches: The first approach involves converting hospital charges (taken from the hospital bill) to costs using the ratios of costs to charges (RCCs) included in each hospital’s annual Medicare Cost Report. This report is built based on annual reporting of every hospital to the Centers for Medicare and Medicaid Services (CMS) that includes details of expenses for direct patient care, overhead, capital equipment, and so forth related to billed charges. Although the Medicare RCCs are not designed for research, it still provides a moderately standardized means of estimating cost across hospitals in the United States. In addition, costs calculated with the RCC method are used to recalibrate diagnosis-related group (DRG) weights by CMS. Therefore this method provides a valuable tool for multicenter cost research. However, this approach has several limitations. First, this approach does not separate out overhead and most other fixed costs and therefore provides only an estimate of average rather than marginal cost, so it may overestimate potential cost savings. Second, due to the complexity of the instructions for reporting to CMS, hospitals may choose to interpret the instructions differently, resulting in significant variability in uncovering hospitals’ actual costs. Finally, the RCCs themselves are an average of all cost-charge relationships from hospital revenue centers, such as the radiology, pharmacy, or laboratory departments; therefore the Medicare whole hospital-level RCCs may not be particularly accurate in converting these charges to costs to reflect individual patient resource consumption. In addition, this method is limited to hospitals using standardized methods of billing, applicable to most but not all U.S. hospitals and to no hospitals outside the United States. Finally, physician costs are not included in this approach.

The second approach depends on calculating the hospital and intervention costs from reimbursement rates for DRGs reported to the CMS by hospitals. This approach also has several limitations. First, it is not sensitive to variations in resource-use intensity within a DRG, as DRG reimbursement rates represent the “average” cost for a particular diagnosis/procedure among all patients in that DRG. Second, the CMS decides in many cases not to increase reimbursement to cover the costs of new technology; therefore the cost of these new technologies may not be well reflected in the DRG. However, this approach does not require collection of hospital bills and, with some assumptions, can potentially be applied to any hospitalization in any health care system, therefore simplifying its use. By assigning DRGs to hospitalizations within studies where DRGs from the hospital bill is not available, this approach can be used for international studies. However, assigning costs to a DRG for hospitalization in international studies is complicated and controversial.

Many studies estimate costs by counting only big-ticket items used (e.g., number of diagnostic cardiac catheterizations, PCIs, or coronary artery bypass graftings (CABGs); days in the intensive care unit [ICU]; total hospital length of stay) and assigning a unit price to each item. The resulting linear formula: Total cost = Σ price × quantity is simple and inexpensive to use (which makes it desirable in clinical research); however, this approach suffers from some significant downsides. First, the source of cost weights is often acquired from available unrelated economic sources external to the resource data being analyzed and therefore of uncertain quality. Second, the appropriate set of big-ticket items necessary to estimate costs accurately by this method has never been rigorously defined. For example, some studies, especially multicenter clinical trials, may use the more easily obtained total hospital length of stay instead of defining specific ICU and non-ICU hospital lengths of stay that may be more representative of accurate cost. Third, most studies treat big-ticket items similarly to preserve the desired simplicity, although they are not necessarily homogeneous. For example, by using payments by the DRG, an uncomplicated single-vessel PCI would typically be assigned the same price as a complex three-vessel PCI or complex graft intervention that was complicated by abrupt closure, while the true costs of these procedures are, in fact, substantially different.

Evaluation of Physician Costs

Evaluating physician costs also has serious challenges. This estimation is also made by one of two approaches. The first approach depends on acquiring the “fee for service” bills from physicians’ offices. This approach had several limitations. First, most patients receive services from several physicians and collecting these bills from multiple offices is a far more complicated process than collecting hospital bills. Second, due to multiple services with different costs and reimbursements in physicians’ offices, cost-shifting process is used to cover for unreimbursed and underreimbursed services without the detailed report of real costs that is required by hospitals when they practice cost shifting. Therefore using “fee for service” bill is not an accurate reflection of the true market price for physician services.

To overcome the limitation of using the physicians’ bill, another approach uses the Medicare Fee Schedule based on the resource-based relative-value scale (RBRVS). An estimation of physician costs can be created using available data from the American Medical Association Physician’s Current Procedural Terminology (CPT). This approach is not ideal, but it has the advantage of being more objective and consistent and might represent the best available U.S. national measure of the economic value of physician work.

Factors That Impact Cost Assessment

The different perspectives of patients, providers, health payers, and society will lead to different assessment of cost. Although patients may consider only out of pocket or copayment costs, health payers may consider the cost of the procedure, associated hospital cost, and whether the medication used is generic or nongeneric. Providers may consider cost in relation to the health benefit for an individual patient and then weigh it against public health implications of this procedure. When assessing the cost of a health service, ideally it should assess not only the immediate cost of the strategy but also consider the overall society perspective, which ultimately rests with all stakeholders in society. Societal costs include the hospital costs, physician fees, outpatient testing, and outpatient drug therapy costs, but also nonmedical direct expenses (e.g., transportation to the medical facility, child care, housekeeping) and the economic impact of lost productivity because of illness.

However, total societal cost cannot be measured effectively because each component is measured by a proxy. To eliminate some of this uncertainty, payer costs are often measured instead. However, payer costs do not represent the complete spectrum of the societal costs. CMS uses DRGs to pay hospitals regardless of the cost of service to the provider, whereas private insurance may use a different scheme to pay providers. Payments may therefore have significant variability between payers.

Furthermore, time effects are important to medical cost analyses because either inflation or deflation will change the cost of a procedure. A common approach to deal with this is to pick a base year and then use the medical inflation rate to deflate all costs in subsequent year to the base year.

Another important factor in determining cost is related to geography. The costs of material and labor inputs to medical care can vary substantially from one part of the United States to another and between large urban university hospitals to small rural community hospitals, creating true differences in cost for medical services according to geography that needs to be adjusted. Several geographic adjustment indices are available, including the Medicare area wage index (for adjusting DRG reimbursement) and the Medicare Fee Schedule geographic adjustment factor. International studies are yet more complex.

Analysis Methods

Several forms of economic evaluations can be performed, and each differs based on the selection and measurement of health outcomes. Although the term “cost effectiveness” is frequently used for all medical economic analyses, cost-effectiveness analysis (CEA) is only one type of assessment. The most basic form of economic evaluation is called a cost-consequence study, which is simply a table that lists the individual economic and health outcomes of alternative interventions. A more advanced but still basic economic form is called cost identification studies that measure only the investment cost of interventions and are used to provide the data needed to better design future studies that consider both the economic and health outcomes of two or more alternative therapies. A more advanced form of economic analysis is called cost minimization analysis (CMA), which differs from cost identification in assuming equivalence in health outcomes among alternative therapies and examines economic outcomes. So even though it examines only economic outcomes, in practice under the assumption of equivalence, a CMA is a form of full economic evaluation.

There are three forms of full economic evaluations that do not assume equivalence of health outcome: CEA, cost-utility analysis (CUA), and cost-benefit analysis (CBA). The definitions and differences between these three forms are summarized in Table 68.1 . Both CEA and CUA are widely used to decide whether a medical intervention is economically attractive, whereas CBA is used much less because it requires measuring all health-related benefits of an intervention or approach in monetary terms without emphasis on either the longevity or quality of the lives involved.

TABLE 68.1
Types of Full Economic Assessment
Cost-Effectiveness Analysis Cost-Utility Analysis Cost-Benefit Analysis
Definition A form of economic-efficiency analysis in which costs are valued in monetary terms and health benefits are valued in natural units. A variant of cost-effectiveness analysis in which the health benefits are expressed in a scale that incorporates both longevity and patient preferences (utilities) for the health states produced. A form of economic-efficiency analysis in which both the costs and outcomes (health benefits) are valued in monetary terms.
Unit of Health Outcomes Natural units (e.g., the number of added life-years (LYs) Summary measure in quality of life units (e.g., quality-adjusted LYs [QALYs]) Summary measure in monetary units (e.g., U.S. dollars)
Results Cost-effectiveness ratio (C1 – C2) / (HB1 − HB2) Cost-utility ratio (C1 − C2) / (QALY1 − QALY2) Net benefits (B1 − B2) − (C1 − C2) or (B1− B2) / (C1 − C2)
B1 , Monetary value of health outcomes of alternative 1; B2 , monetary value of health outcomes of alternative 2; C1 , total costs of alternative 1; C2 , total costs of alternative 2; HB1 , health benefit of alternative 1; HB2 , health benefit of alternative 2; QALY1 , quality-adjusted life-years of alternative 1; QALY2 , quality-adjusted life-years of alternative 2.

The primary goal of CEA is to evaluate different health care intervention options in common terms so that policy and other decision makers can be informed of the most efficient method of producing extra health benefits from among the alternative ways that health care dollars can be distributed. In both CEA and CUA the metric used to assess incremental cost effectiveness is the incremental cost-effectiveness ratio (ICER). An ICER is defined as the ratio of incremental costs to incremental health benefits or ICER = (C1 − C2) / (HB1 − HB2), where C1 and C2 are cost for treatment 1 and 2, respectively, and HB is the health benefit of treatment 1 and 2, respectively.

ICER is a ratio that has a distribution because there is uncertainty in both cost and effectiveness measurements. When patient-level data are available, it is possible to consider the uncertainty in both cost and effectiveness due to the play of chance (i.e., stochastic error). To examine the confidence intervals of cost and effectiveness due to the play of chance, an approach called bootstrap analysis is widely used. It depends on sampling both the cost and effectiveness distributions concurrently which allows for multiple estimates of the ICER to be made, plotted as a pictorial four quadrant distribution ( Fig. 68.1 ): (1) Quadrant A: the new therapy is more effective and more costly than the previous standard; (2) Quadrant B: the new therapy dominates the standard, being more effective and less expensive; (3) Quadrant C: the new therapy is less effective and less expensive; and (4) Quadrant D: the new therapy is dominated by the standard, being less effective and more expensive. The dots represent the individual estimations of the ICER from the dual bootstrap analysis.

Fig. 68.1, Distribution of cost effectiveness.

The ICER defines the cost that should be assumed for gaining one unit of output. In other words, if one of the alternatives is the usual practice, then it will tell us how much it will cost to gain a unit of outcome when moving from the usual practice to the alternative. The health benefit may be measured in any sensible unit, such as number of MIs averted, but most economics use the conventional option of measuring clinical benefits as either the number of added life-years (LYs) or quality-adjusted life-years (QALYs). Both of these approaches require estimation of life expectancy with and without the intervention being considered.

Although LYs are conceptually simple because its estimation depends only on survival, many therapies are used primarily to improve quality of life rather than to increase longevity, and therefore a broader measurement of QALYs is needed. To estimate QALYs, it is first necessary to estimate utility. Utility is defined as the relative desirability of a particular health outcome or health state, assessed as the preference of a rater (typically a patient or a member of the general public) for that outcome relative to the defined and extreme alternatives (e.g., death, excellent health). Every health state will have a unique utility. In health care economics, utility is generally scaled from 0 to 1, with a utility of 0 for death and 1 for perfect health and functioning. The relationship between utility and cost can be assessed by CUA with the use of QALYs, which is life expectancy multiplied by utility. The value of 1 year of life in excellent health would be represented by 1.0 QALY (i.e., 1 life-year multiplied by a utility of 1).

Utility Assessment

Utility may be measured by patient preference methods or by surveys that have been mapped to patient preference methods. Theoretically, the best direct measure of utility is the “standard gamble” method because it assesses both overall quality of life and risk aversion. However, this measure is complex to obtain and may not be practical to administer in large trials. Most economic analyses derive utilities from surveys (e.g., EQ-5D or the Health Utilities Index). Using this approach, patient health states are defined by a number of explicit domains such as physical functioning and pain. Then, previously measured utility weights from patients (i.e., those with the condition of interest) or the general public (i.e., those who are at risk for getting the condition of interest) are assigned to each possible health state.

Time Horizon and Discounting

The time horizon of an analysis reflects the length of time over which clinical health benefits and costs should be considered and included in the analysis. The time frame should be the same for both the clinical outcomes and costs. Although the time for many trials may be limited to either short or intermediate time horizon secondary to limitations related to budgets and enrollment, the evaluation of cost effectiveness from the societal perspective requires applying a long-term or lifetime time horizon.

Assessing the cost effectiveness over a lifetime horizon requires assessing both the future costs and health benefits. Future costs and health gain are commonly weighted in relation to the time at which they occur, and usually future costs and health effects receive less weight than present ones. This process is called discounting.

The idea behind discounting comes from the assumption that money available or spent now is more valuable than money available or spent in the future, because money available now can be put to immediate use. Because costs are discounted, the benefits of health interventions must also be discounted. It is important to emphasize that discounting is not an adjustment for inflation, which is a separate consideration. As even in the absence of inflation, most individuals would prefer to have an equivalent health benefit or money now as opposed to in the future. The discount rate captures this time preference. When data regarding costs are derived from different years, older costs are usually inflated to their equivalent values in more recent years so that there can be a consistent economic basis. If future medical inflation costs rise uniformly, then future purchasing power for health care remains the same, and there is no need to adjust for medical inflation.

Sensitivity Analysis

Even in the most carefully conducted cost-effectiveness studies, considerable uncertainty may remain regarding the parameters used to measure costs and health effects. This uncertainty is in addition to accounting for the play of chance with bootstrap analysis, which is not sufficient to account for any additional uncertainty or bias. To identify and assess the degree to which uncertainty in the parameter could affect the overall results, CEAs usually perform multiple evaluations in which one or more of the parameters are varied across reasonable ranges. The ranges reflect intrinsic variability or regional variation. As an example, the cost of diagnostic cardiac catheterization may be cheaper in some institutions or health care delivery settings compared with others; thus to determine the cost effectiveness of PCI in stable coronary artery disease (CAD), the cost of PCI could be varied over a range to determine the maximal cost at which it remains cost effective. This process (termed “sensitivity analysis”) allows for a reasonable appraisal about the parameters that are most important in the analysis and the stability of the reference case results.

Sensitivity analyses have typically assessed the effect varying selected parameters related to cost effectiveness one at a time. A more contemporary approach called Monte Carlo simulation permits all parameters to be varied simultaneously. These sophisticated analyses yield a cost-effectiveness acceptability curve, which accounts for uncertainty in all model estimates. The end result is that the curve displays the likelihood that a new intervention will have a cost-effectiveness ratio that falls below a particular societal “willingness to pay.” (See Benchmarks in Economic Analysis later.)

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