Ethics of new emphasis on comparative effectiveness
Cost-effectiveness is related issue
The Affordable Care Act (ACA) will put more emphasis on both comparative effectiveness and cost-effectiveness, and this raises important ethical considerations, according to Gary E. Jones, PhD, JD, professor in the Philosophy Department at University of San Diego (CA).
Jones notes that it is anticipated that under the ACA, a majority of the nearly 50 million Americans who presently lack insurance coverage will obtain at least a minimal level of health insurance.
"A nearly universal concern, however, is the overall cost associated with the ACA," he says. "The United States spends in excess of $2.65 trillion on health care. This amount is greater than that spent by any other country, both in terms of total amount as well as per capita."
Nonetheless, according to the Institute of Medicine, more than half of treatments rendered are not supported by evidence that they are effective.1 "Consequently, in the last several years, there has been an interest in establishing the comparative effectiveness of treatments," says Jones.
Research is ongoing
The Institute of Medicine defines comparative effectiveness research as "the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or improve the delivery of care."1
Comparative effectiveness research has been performed in the United States for many years by the National Institutes of Health (NIH), the Agency for Healthcare Research and Quality (AHRQ), and the Department of Veterans Affairs, notes Jones, and was addressed in the American Recovery and Reinvestment Act (ARRA), adds Jones.
"ARRA earmarked $1.1 billion for research to be overseen by NIH, AHRQ, and the Office of the Secretary of Health and Human Services," he says. "To monitor the expenditure of funds, ARRA created a Federal Coordinating Council for Comparative Effectiveness Research."
The funds provided by ARRA constituted the initial stage of a more comprehensive comparative effectiveness research effort, says Jones. "The ACA established a new, nongovernmental entity, the Patient-Centered Outcomes Research Institute, to oversee the research," he says. "The ACA also established a source of funding for the research."
Beginning this year, Medicare and all private health insurance companies will pay a tax into a trust fund that will support the activities of the new Institute. "Thus, comparative effectiveness research will continue for the foreseeable future," says Jones.
Physician-patient relationship
The concepts of comparative effectiveness and cost-effectiveness "may be related, but are not identical," says Jones. The ACA defines cost-effectiveness as "an economic analysis that compares the relative costs and outcomes of two or more courses of action (or nonaction)," and defines comparative effectiveness research as "research evaluating and comparing health outcomes and the clinical effectiveness, risks, and benefits of two or more medical treatments, services, and items."2,3
"Investigations of comparative effectiveness of treatments could — perhaps even should — ultimately result in calculations of the cost-effectiveness of treatments," says Jones. The results could ultimately be used to allocate government resources or mandate treatment decisions, he says, and as a result, the informed consent process might be affected.
"Physicians might be influenced to recommend to their patients only those treatments for which there is reimbursement," explains Jones. As a result, investigations into comparative effectiveness could influence the physician-patient relationship, he says.
"Will the United States adopt a system such as the metric called quality-adjusted life years, utilized in the United Kingdom to establish health outcomes as a basis for making cost-effectiveness determinations?" he asks. "Such concerns are unfounded — at this point."
Cost-containment is a concern
Issues of cost-effectiveness research are generally not addressed in the comparative effectiveness research programs established in the ACA, adds Jones. "Indeed, the federal government is prohibited from using algorithms based on measurements such as quality-adjusted life years to determine coverage, reimbursement, or incentive programs under Medicare," he says.
The ACA forbids the government from using cost-effectiveness estimates "as a threshold to determine coverage, reimbursement, or incentive programs" under Medicare. The government is also forbidden from making decisions relating to "coverage, reimbursement, or incentive programs" under Medicare "in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill."2,3
Therefore, says Jones, "considerations of cost will likely not have any direct bearing on the physician-patient relationship or on the informed-consent process in the foreseeable future."
However, the emphasis on the effectiveness of treatments will remain a significant issue due to efforts to contain future medical costs, according to Jones. "Not only the comparative effectiveness of treatments, but their cost-effectiveness, are issues that deserve continued attention," he says.
References
- Institute of Medicine, Board on Health Care Services, "Initial National Priorities for Comparative Effectiveness Research," June 30, 2009. The National Academies Press, Washington, DC.
- P.L. 111-148, Patient Protection and Affordable Care Act.
- P.L. 152, Patient Protection and Affordable Care Act.
Source
- Gary E. Jones, PhD, JD, Philosophy Department, University of San Diego (CA). Phone: (619) 260-4089. E-mail: [email protected].
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