The Patient Protection and Affordable Care Act established a fund to support research comparing the effectiveness of available treatments. This research can help patients, doctors, and others make decisions to improve health care.

We found that the Patient-Centered Outcomes Research Institute and Department of Health and Human Services expect to receive about $4 billion from the fund by the end of fiscal year 2019.

The money has primarily funded research and helped facilitate getting findings to the patients, doctors, and others who can use them. Most of the funded research will be completed in the coming years.

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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.

PCORI's Actual and Projected Commitments and Expenditures, Fiscal Years 2010 through 2024 (Dollars in Millions)

Note: Amounts listed are current as of Jan. 5, 2018.

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.

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.

For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.