ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: A report of the American college of cardiology/American heart association task force on performance measures and task force on practice guidelines

Traditionally, resource utilization and value considerations have been explicitly excluded from practice guidelines and performance measures formulations, although they often are implicitly considered. This document challenges this historical policy. With accelerating healthcare costs and the desire to achieve the best value (health benefit for every dollar spent), there is growing recognition of the need for more explicit and transparent assessment of the value of health care. Thus, from a societal policy perspective, a critical healthcare goal should be to achieve the best possible health outcomes with finite healthcare resources. Consideration of cost/resource utilization as an outcome presents special challenges. Frequently, the scientific evidence base is inadequate to accurately assess cost-benefit. Also, costs may vary widely by practice setting, locality, and nationality, and over time. Moreover, individuals bear the burden of adverse health outcomes, yet costs typically are shared by society (eg, by families, employers, government, premium payers, fellow employees, taxpayers). Finally, attitudes differ among stakeholders about the extent to which cost should influence treatment decisions for individual patients and who should bear these costs. Consequently, resource utilization debates often become highly politicized, and significant conflicts of interest among individuals impaneled to formulate resource-based guidelines may be difficult to avoid. A transparent and consistent approach to considering value is needed when making healthcare decisions. This must begin with an understanding of key economic concepts, including allocation of resources to produce more health care of various types, methods for assessing the monetary value of these resources, and the perspective used for making this assessment of the value of healthcare expenditures (ie, societal perspective, individual patient costs, hospital costs, and payer costs). Methodological challenges include limitations in the robustness and quality of value evidence, regional variations in costs, and outdated (temporally dynamic) and biased data. Despite these challenges, the writing committee agreed that progress has been made in these areas and that the need for greater transparency and utility in addressing resource issues has become acute enough that the time has come to include cost-effectiveness/value assessments and recommendations in practice guidelines and performance measures. The writing committee chose to emphasize the nomenclatures of "value" and "resource utilization" over "cost." Given evidence and resource limitations, the writing committee also recognized the need to selectively target guidelines and performance measures for initial resource use evaluation. A plan for performing a thorough, independent literature search and a consistent method for assessing the quality and potential for bias of identified articles should be prospectively designated. The evidence base then should be synthesized to provide an overall value classification together with a supporting level of evidence, which should be reported alongside but separate from the scientific class and level/quality of evidence. The proposed level of value (LOV) categories, outlined in Section 5 of this paper, are high value (H), intermediate value (I), and low value (L), augmented as appropriate with uncertain value (U) and value not assessed (NA). For example, high value might be set at <$50 000 and low value at >$150 000 per quality of life-year added, indexed to gross domestic product (GDP) or as otherwise determined by agreed-on societal norms. The value category (ie, H, I, L, U) would be supplemented by a level/quality of evidence paralleling those for scientific level of evidence (ie, A, B, and C) and based on the robustness of the database supporting the value category. These value assessments would also inform development of performance measures. Class I recommendations determined to be of low value would not be recommended as performance measures. Because the value of a given care practice will change if the cost or benefit of the practice changes, timely review and updates of guidelines will be even more important when value determinations are included in the guidelines. This report stresses that the value category should be only one of several considerations in medical decision making and resource allocation. Providers and society may be willing to pay more for the only effective treatment for a rare disease (eg, congenital versus adult cardiac care). As noted, given differing methodologies, quality of evidence, and temporal and geographic dynamics of resource and value assessments, the value level of a recommendation should be given separately and not averaged together with the level/quality of evidence from clinical trial results as a single metric. It is anticipated that these will usually be concordant, but in some cases, discordance may be noted (eg, an intervention is shown to provide a small incremental health care benefit but at a high cost in resources). Defining how medical decision making should be affected in specific instances by such discordance between value and guideline recommendations is controversial, but highlighting these instances explicitly and transparently will further inform appropriate discussion and policy making.