	Background

In 2010 PPACA authorized the establishment of PCORI to improve CER  quality and relevance. PPACA also established requirements for HHS to,  among other things, disseminate findings from federally funded CER,  including findings published by PCORI, and coordinate with relevant  federal health programs to build data capacity for research. PPACA  established a Trust Fund to fund these CER activities by PCORI and HHS  through fiscal year 2019. PPACA Funding for CER

PPACA established the Trust Fund through which PCORI and HHS  receive funds for CER activities. The law provides that for fiscal years  2010 through 2019, the Trust Fund will receive appropriations from the  general fund of the Treasury, transfers from the Medicare trust funds, and  fees collected by the Department of the Treasury (Treasury) from private  insurance and self-insured health plans. 1 for an overview of transfers  to the Trust Fund and distribution of funds to PCORI and HHS). PCORI Committed Funds Primarily to Research and Data Capacity Efforts; Awards for Dissemination and Implementation of Findings Were Limited as Most Research Was Still Underway

In fiscal years 2010 through 2017, PCORI committed about $1.6 billion  (or 79 percent of its total award commitments of $2.0 billion) to awards for  conducting CER and $325 million (or 16 percent) to awards for building  data capacity for research. In  addition to awards, the total includes PCORI’s expenditures for program  and administrative support services in fiscal years 2010 through 2017, as  well as projected expenditures for these services through fiscal year  2024. 2 for PCORI’s actual and projected commitments and  expenditures and see app. Officials from all but one of the stakeholder organizations we  interviewed—public and private payers, health care providers, and patient  advocacy organizations that represented potential users of CER— generally supported PCORI’s research award priorities. PCORI projects to  commit an additional $91 million for these awards in fiscal years 2018  through 2021. HHS Obligated Funds Primarily for the Dissemination and Implementation of Research

Between fiscal years 2011 and 2017, HHS’s AHRQ obligated about $260  million (or 58 percent of HHS’s $448 million in total obligations) for the  dissemination and implementation of CER findings. According to AHRQ  officials, because most PCORI-funded research had not been completed  by the end of fiscal year 2017, these efforts were primarily focused on the  dissemination and implementation of research funded by other entities,  including NIH and the Centers for Disease Control and Prevention (CDC). Additionally, AHRQ obligated $94 million for efforts to train researchers  on conducting CER, and ASPE obligated $85 million for efforts to build  data capacity. Dissemination and Implementation

During fiscal years 2011 through 2017, AHRQ obligated a total of $260  million for CER dissemination and implementation initiatives and plans to  obligate an additional $93 million for these initiatives in fiscal years 2018  through 2020. The “Clinical Decision Support (CDS) Initiative” is designed to use  CDS to promote the timely incorporation of CER findings into  clinical practice. PCORI and HHS provided technical comments, which we  incorporated as appropriate. Disseminates CER findings published by the Patient-Centered Outcomes Research Institute  (PCORI) and other government entities to providers, patients, payers, and others. PCOR is a form of CER.
Why GAO Did This Study

In 2010, the Patient Protection and Affordable Care Act (PPACA) authorized the establishment of PCORI to carry out CER and improve its quality and relevance. PPACA also established new requirements for HHS to, among other things, disseminate findings from federally funded CER, including findings published by PCORI; and coordinate with relevant federal health programs to build data capacity for this research. To fund CER activities, PPACA established the Trust Fund from which PCORI and HHS are expected to receive an estimated $4.0 billion from fiscal years 2010 through 2019.
PPACA included a provision for GAO to review PCORI's and HHS's use of the Trust Fund. This report examines (1) PCORI's use of the Trust Fund for CER activities, including the dissemination and use of research findings; and (2) HHS's use of the Trust Fund for these activities.
GAO examined PCORI and HHS documents and data related to use of the Trust Fund, such as commitment, obligation, and expenditure data; PCORI's audited financial statements; and descriptions of CER activities. GAO also interviewed PCORI and HHS officials responsible for planning and carrying out CER activities and interviewed officials from stakeholder organizations representing potential users of CER, including public and private payer organizations, provider organizations, and patient organizations. PCORI and HHS provided technical comments, which GAO incorporated as appropriate.

What GAO Found

The Patient-Centered Outcomes Research Institute (PCORI) made about $2 billion in commitments for awards in fiscal years 2010 through 2017. PCORI is a federally funded, nonprofit corporation established to carry out and improve comparative clinical effectiveness research (CER), which evaluates and compares the health outcomes and the clinical effectiveness, risks, and benefits of two or more medical treatments, services, or items. PCORI provides funding through award commitments from the Patient Centered Outcomes Research Trust Fund (Trust Fund) and may pay these awards over multiple years. Of the $2 billion PCORI committed as of the end of fiscal year 2017, about $1.6 billion (or 79 percent of its commitments) is for research awards, and $325 million (or 16 percent) is for building the capacity to use existing health data for research. Through fiscal year 2017, commitments for dissemination and implementation awards—intended to share CER findings with potential users of this research—were limited because most PCORI-funded research was still underway. PCORI projects to commit an additional $721 million for awards in fiscal years 2018 through 2021. In addition to awards, PCORI spent $310 million on program and administrative support services in fiscal years 2010 through 2017 and projects to spend an additional $206 million for these services through fiscal year 2024.
From fiscal years 2011 through 2017, the Department of Health and Human Services (HHS) obligated about $448 million from the Trust Fund. Of this amount, HHS obligated about $260 million (or 58 percent of all obligations) to the dissemination and implementation of CER findings. As most PCORI-funded CER had not yet been completed due to the time needed to conduct this research, HHS efforts focused instead on the dissemination and implementation of CER funded by other federal entities. Additionally, HHS obligated funds for efforts to train researchers on conducting CER, build data capacity, and on administrative activities. HHS projects to obligate an additional $120 million for these activities in fiscal years 2018 through 2020.