April 1, 2014 — Citing accelerating healthcare costs and finite resources, the American College of Cardiology (ACC) and the American Heart Association (AHA) announced they will begin incorporating value assessments into their clinical documents.
The ACC and AHA elaborated on their decision, outlining the reasons for adding value assessments, reviewing the economic concepts associated with such assessments, and proposing a value ranking system in the ACC/AHA Statement on Cost/Value Methodology in Guidelines and Performance Measures. In addition, they highlighted future directions and needs.
“There is growing recognition that a more explicit, transparent and consistent evaluation of healthcare value is needed,” said Paul Heidenreich, M.D., writing committee co-chair and vice-chair for quality, clinical affairs and analytics in the department of medicine at Stanford University School of Medicine. “These value assessments will provide a more complete examination of cardiovascular care, helping to generate the best possible outcomes within the context of finite resources.”
The societies’ historical policy has been to only explicitly consider clinical efficacy and outcomes when drafting practice guidelines and performance measures. The document highlights that a “proposed level of value” will be added, with categories that include “high value,” “intermediate value,” “low value,” “uncertain value” and “value not assessed.” The level of value will be accompanied by a level of evidence ranking (A, B, C) that shows the type of information used to make the value decision.
To determine the level of value, the societies propose using the “quality-adjusted life-year” (QALY), a standard outcomes measure in economic evaluation. They further suggest utilizing the World Health Organization’s cost effectiveness benchmark — three times a country’s GDP per capita — as an upper threshold. Using this benchmark in the U.S. system, treatments that have a cost effectiveness ratio of $150,000/QALY or more would be considered low value.
Illustrating the need for more careful resource allocation, the statement cites data about increases in healthcare spending. According to data from the Henry J. Kaiser Foundation, U.S. per capita spending doubled between 1997 and 2010 and now consumes 17.9 percent of the GDP. At the state level, spending for Medicaid now surpasses that of all funding spent on education for kindergarten through 12th grade.
In addition, the statement cites the Dartmouth Atlas Project, which has for decades documented significant regional variations in care without substantial differences in health outcomes.
While the statement provides compelling data on the need for change, it acknowledges the challenges involved in conducting value assessments. For example, treatment costs change over time and vary by location, complicating the evaluation process. Additionally, there is no national consensus about the extent to which cost should influence treatment decisions. Further, a limited number of cost effectiveness studies exist to provide the necessary evidence base.
Acknowledging these issues, the statement notes that momentum is increasing in the area of healthcare cost effectiveness and that the incorporation of value assessments in clinical guidance documents may further incentivize researchers, medical schools and other stakeholders to invest in the country’s move toward greater care value.
“Despite the dearth of cost effectiveness research, the evidence that is available is informative, and study quality is improving,” said Jeffrey L. Anderson, M.D., writing committee co-chair and associate chief of cardiology, Intermountain Medical Center Heart Institute. “The hope of the writing committee is that this statement will further encourage researchers to include a value component in their study designs, providing an analysis of resource utilization and cost-benefit in multicenter trials.”
The societies caution that the new value category should be only one of several factors considered when making decisions about resource allocation. According to the statement, the level of value should be “broadly considered” while also looking at the risk-benefit ratio and the level/quality of evidence for the specific clinical recommendation in a specific patient. It adds that providers and society may be willing to pay more if a treatment is the only one available for a rare disease.
Finally, while the statement notes that the societies will “not yet be prescriptive” in how best to use the value assessments at the point of care, it does provide general ideas on their responsible integration, as well as on their potential benefit to patients and the public. “The ACC and AHA recognize that payers, providers and patients may have different views on how to incorporate value into medical care, but they all will benefit from having more cost and value data available,” said Heidennreich.