GAO Report: Comparative Effectiveness Research — Activities Funded by the Patient-Centered Outcomes Research Trust Fund

In March, 2018, the Government Accountability Office (GAO) released a publication which reviews the awarded commitments provided by the Patient-Centered Outcomes Research Institute (PCORI) and the corresponding expenditure data from the Patient-Centered Outcomes Research Trust Fund (Trust Fund) as well as the HHS data on obligated funds to publish the PCORI findings and build data capacity for the research.

As background, PCORI is a federally funded, nonprofit corporation authorized by the ACA to improve the quality and relevance of evidence through research to help patients, clinicians, purchasers and policymakers to make informed health care decisions. In short, PCORI exists to improve comparative clinical effectiveness research (CER). The ACA also requires HHS to publish the findings from the CER, including those provided by PCORI, and to coordinate with relevant federal health programs to handle the research. Funding for this research is collected from the general fund of the Department of Treasury (Treasury), transfers from the Medicare trust funds, and fees collected by the Treasury from private insurance and self-insured health plans.

The ACA charged the GAO to review PCORI’s use of federal funding by 2018. For this report, the GAO analyzed: (i) the PCORI’s use of the commitments made for the Trust Fund for comparative CER activities, including the distribution of the research findings and (ii) HHS’s use of the Trust Fund for these activities.

The GAO findings in this review were limited, because most research is still underway. Only 53 of the 543 research projects were completed as of the end of fiscal year 2017, because the CER process from initial proposal stage to publishing the research may take up to six years to complete. To date, PCORI has committed about $2 billion for awards in 2010-2017. About 79 percent of the $2 billion is for research awards ($1.6 billion) and 16 percent is to build the capacity to use existing health data to conduct the research. PCORI projects to commit an additional $721 million in fiscal years 2018-2021. Of the current committed funds, health conditions that received the highest PCORI research award commitments include mental and behavioral health, cancer, cardiovascular disease, neurological disorders and patients suffering from multiple chronic conditions.

HHS has committed $448 million from the Trust Fund, a majority of which was to distribute and implement CER findings. Similar to the situation at PCORI, a majority of the research is still being completed, and the CER has yet to be done. HHS plans to spend $120 million in fiscal years 2018-2020 to satisfy the obligation to train researchers on conducting CER, build data capacity and perform administrative activities.

The report contains no new employer obligations, but employers may be interested in reviewing it to gain a better understanding of the PCORI.

The GAO Report of PCORI’s use of federal funds »
The GAO Report of PCORI’s research activities published in 2015 »