Recovery Act to Fund Comparative Effectiveness Trials

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In August, 2008, Senate Finance Committee Chair Max Baucus (D–MT) and Senate Budget Committee Chair Kent Conrad (D–ND) introduced legislation to establish a public–private comparative effectiveness institute. Many health policy experts have called for such an initiative as necessary to control costs and improve quality. The senators envisioned this institute as a nonprofit, private entity, not a federal agency, governed by a public–private board. Indeed, Peter Orszag, Congressional Budget Office Director, estimates that the United States could save up to $700 billion annually in health spending if treatments that do not lead to the best medical outcomes could be avoided.

The agency, which is named the Health Care Comparative Effectiveness Research Institute, would set national priorities and would work with National Institutes of Health, the Agency for Health Care Research and Quality (AHRQ), and private entities to provide peer-reviewed research. Comparative effectiveness studies would directly compare risks and benefits of different treatments for particular conditions and are considered essential for slowing cost increases and improving delivery of services. But health policy experts note that a research agenda that targets the most costly types of treatments and produces findings that shrink demand for those treatments may not sit well with individual drug, device, and medical professionals affected.

Enter the American Recovery and Reinvestment Act of 2009 (ARRA), in which the Obama administration has allocated $1.1 billion for comparative effectiveness research (CER). Of this amount, $300 million would be administrated by AHRQ, $400 million by the National Institutes of Health, and $400 million by the secretary of Health and Human Services. With ARRA money, experts agree that many such trials could be sponsored by the government, along with clinical data networks and systematic reviews. The recovery Act also includes funds for an Institute of Medicine contract to recommend by June 2009 “national priorities for comparative effectiveness research.”

The ARRA includes language creating the Federal Coordinating Council for Comparative Effectiveness Research. This council will coordinate CER and will advise Congress and the President on strategies regarding the infrastructure needs (for CER) within the federal government. The proposed language also provides funds to existing government programs within AHRQ that have already initiated CER. The new act also highlights the importance of including women and minorities in CER trials.

However, concerns have arisen about the possibility that CER findings could lead to treatment rationing, as it has elsewhere in the world. According to Phyllis Greenberger of the Society for Women's Health Research, although “the law does ensure that ‘subpopulations are considered when research is conducted,' this is hardly a guarantee that comparative effectiveness research won't one day be abused at the expense of patients in the United States.”