Stakeholders weigh in on research design and use of data
As a result of the recent economic stimulus act, there will soon be a surge of comparative effectiveness research (CER) aimed at better understanding and comparing the clinical merits of different treatments, devices and procedures.
The American Recovery and Reinvestment Act (ARRA) allocated $1.1 billion to "accelerate the development and dissemination of research assessing the comparative effectiveness of health care treatments and strategies." The law specifically allocated $400 million to the National Institutes of Health (NIH), $300 million to the Agency for Healthcare Research and Quality (AHRQ) and $400 million to be dispersed at the discretion of the Secretary of Health and Human Services (HHS).
Coordination and oversight of the research funds have been assigned to a federal coordinating council comprised of 15 federal employees. Over the coming months, the council will be seeking input from stakeholders as it prepares to present Congress with an operations plan by July 30. The first in a series of public listening sessions will be held on April 14. The HHS Secretary will also be advised by the Institute of Medicine (IOM), which has been charged with providing recommendations on national funding priorities.
While CER has been occurring for decades across the U.S. in both private and public sectors, the money apportioned from the stimulus package may be a harbinger of a much greater expansion. The concept of CER is gaining in popularity among a segment of policymakers as a means of improving the health care system and reducing costs. The support is not universal, however, and as Congress debates health care reform, comparative effectiveness is promising to be at the center of a surprisingly intense, partisan debate on Capitol Hill.
At its best, proponents believe that CER could lead to a more efficient, less expensive health care system by increasing the amount of information available to patients and their physicians when making personal treatment decisions and by reducing ineffective or unproven care.
At its worst, however, there is fear that CER could ultimately lead to health care rationing where patients are denied potentially lifesaving treatments simply on the basis of cost.
There are also concerns that if CER study designs fail to take into account patient individuality, the resulting data could be misused by insurance providers to make one-size-fits-all coverage decisions. Minority and disability groups, for example, have expressed concerns that most CER to date has not taken into account a broad enough population sample.
In response to some of these concerns, a report accompanying the ARRA expounded on the point that CER funding should not be used to "mandate coverage, reimbursement, or other policies" and recognized that "a "one-size-fits-all" approach to patient treatment is not the most medically appropriate solution to treating various conditions." The ARRA does not, however, rule out the inclusion of cost in stimulus-funded CER. The NIH recently gave an indication that it would not shy away from supporting CER that considers cost as a factor in comparison with the $10 billion it received in the act or the $400 million expressly allocated to CER. During a hearing of the House Appropriations Labor-HHS-Education Subcommittee in late March, Dr. Raynard S. Kington, the acting director of the NIH, testified that "if we receive high-quality applications that meet the definition for comparative effectiveness that include cost, we will fund them." He asserted the potential of such research to "complement the movement toward personalized medicine" by increasingly integrating more detailed information at the individual level.
Recognizing the impact that CER could have on the health care system, a wide range of constituencies, from patient advocacy groups to providers, payers, industry and regulators are becoming increasingly vocal on the subject. At issue for most stakeholders is not whether or not the federal government should pursue CER but the framework it establishes for the generation and use of such research findings.
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