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Patient-Centered Outcomes Research Institute: Review of the Audit of the FY 2021 Financial Statements

GAO-22-105587 Published: Mar 29, 2022. Publicly Released: Mar 29, 2022.
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Fast Facts

The Patient-Centered Outcomes Research Institute is a federally funded, nonprofit corporation that was established to fund and evaluate research aimed at helping patients, doctors, and policymakers make better health care decisions.

PCORI is required to have its financial statements audited annually, and we're required to review those audits. PCORI's auditor issued an unmodified (clean) opinion on its fiscal year 2021 financial statements, concluding that these fairly presented PCORI's financial position and activities.

We reviewed certain aspects of this financial audit and found no significant issues requiring attention.

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What GAO Found

Based on the limited procedures GAO performed in reviewing the independent public accounting firm's (IPA) financial audit of the Patient-Centered Outcomes Research Institute's (PCORI) fiscal year (FY) 2021 financial statements, GAO did not identify any significant issues that it believes require attention. Had GAO performed additional procedures, other matters might have come to its attention that it would have reported. The IPA provided an unmodified audit opinion on PCORI's FY 2021 and 2020 financial statements. Specifically, the IPA found PCORI's financial statements were presented fairly, in all material respects, in accordance with U.S. generally accepted accounting principles. Further, for FY 2021, the IPA did not identify any deficiencies in internal control that it considered to be material weaknesses or any reportable noncompliance with the selected provisions of laws, regulations, contracts, and grant agreements it tested. PCORI agreed with the IPA report's conclusions.

GAO provided a draft of its report to PCORI and the IPA for review and comment. PCORI's Director of Finance and an IPA partner responded that they had no comments on GAO's report.

Why GAO Did This Study

This report presents the results of GAO's review of PCORI's FY 2021 financial statement audit. The Patient Protection and Affordable Care Act (PPACA) created PCORI in 2010 as a federally funded, nonprofit corporation that is neither an agency nor establishment of the United States government. According to the act, PCORI's purpose is to assist patients, clinicians, purchasers, and policymakers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis.

The act requires PCORI to obtain an annual financial statement audit from a private entity with expertise in conducting financial audits. The act also requires the Comptroller General of the United States to review the audit and report the results to the Congress annually. GAO's objective was to review the financial audit of PCORI's FY 2021 financial statements. To satisfy this objective, GAO performed the following procedures: (1) read and considered various documents relating to the IPA's independence, objectivity, and qualifications; (2) analyzed key IPA audit documentation; (3) read PCORI's FY 2021 and 2020 financial statements, the IPA's audit report on the financial statements, and the IPA's report on internal control over financial reporting and compliance; and (4) met with IPA representatives and PCORI management officials.

For more information, contact Beryl H. Davis at (202) 512-2623 or

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Federal fundsFederally funded researchFinancial auditsFinancial reportingFinancial statement auditsFinancial statementsNonprofit organizationsInternal controlsQuality controlHealth care