GAO Review of PCORI's FY 2025 Financial Audit

GAO Reports

Published March 26th, 2026

Detected March 26th, 2026

Summary

The GAO has reviewed the Patient-Centered Outcomes Research Institute's (PCORI) FY 2025 financial audit. The review found no significant issues, and PCORI's auditor issued an unmodified opinion on its financial statements. PCORI concurred with the auditor's conclusions.

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What changed

The Government Accountability Office (GAO) has completed its review of the independent auditor's report on the Patient-Centered Outcomes Research Institute's (PCORI) fiscal year 2025 financial statements. The GAO performed limited procedures and found no significant issues requiring attention. The independent auditor issued an unmodified opinion, indicating PCORI's financial statements fairly presented its financial position and activities, and found no material weaknesses in internal controls or reportable noncompliance with laws and regulations for FY 2025.

This report is a routine annual review as mandated by the Patient Protection and Affordable Care Act. While the GAO's review did not identify any issues, it was not an audit of PCORI's financial statements themselves. PCORI concurred with the auditor's findings. Compliance officers should note that this is an informational notice confirming the integrity of PCORI's financial reporting for FY 2025, with no new compliance obligations or actions required.

Source document (simplified)

GAO-26-108882 Published: Mar 26, 2026. Publicly Released: Mar 26, 2026.

Fast Facts

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

The institute is required to have its financial statements audited annually, and we're required to review those audits. The institute's auditor issued an unmodified (clean) opinion on its FY 2025 financial statements, concluding that they fairly presented the institute's financial position and activities.

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

Highlights

What GAO Found

Based on the limited procedures GAO performed in reviewing the independent public accounting firm's (IPA) fiscal year 2025 audit of the Patient-Centered Outcomes Research Institute's (PCORI) 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 fiscal years 2025 and 2024 financial statements. Specifically, the IPA found that PCORI's financial statements were presented fairly, in all material respects, in accordance with U.S. generally accepted accounting principles. Further, for fiscal year 2025, 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 concurred with the IPA's conclusions.

GAO's review of PCORI's fiscal year 2025 financial statement audit, as differentiated from an audit of the financial statements, was not intended to enable GAO to express—and it does not express—an opinion on PCORI's financial statements or conclude on the effectiveness of its internal control over financial reporting. Furthermore, GAO does not express an opinion on PCORI's compliance with provisions of applicable laws, regulations, contracts, and grant agreements. The IPA is responsible for its reports on PCORI dated February 11, 2026, and the conclusions expressed therein.

GAO provided a draft of its report to PCORI and the IPA for review and comment. PCORI's Chief Financial Officer provided technical comments, which GAO incorporated in the final report. An IPA partner responded that the IPA had no comments on the draft report.

Why GAO Did This Study

This report presents the results of GAO's review of PCORI's fiscal year 2025 financial statement audit. PCORI is a federally funded, nonprofit corporation that is neither an agency nor establishment of the U.S. government. PCORI's purpose is to help patients, clinicians, policymakers, and others make informed decisions about health and health care options.

The Patient Protection and Affordable Care Act requires PCORI to obtain an annual financial statement audit from a private entity with expertise in conducting financial audits. The act includes a provision for 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 results of PCORI's fiscal year 2025 financial statement audit. To satisfy this objective, GAO (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 fiscal years 2025 and 2024 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 Cheryl E. Clark at clarkce@gao.gov.

Full Report

Full Report (7 pages)

GAO Contacts

Cheryl E. Clark Director Financial Management and Assurance clarkce@gao.gov

Media Inquiries

Sarah Kaczmarek Managing Director Office of Public Affairs media@gao.gov

Public Inquiries

Topics

Auditing and Financial Management Financial statements Internal controls Financial reporting Financial audits Compliance oversight Quality control Financial management Health care Peer review Professional standards