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GAO Report Reviews PCORI and HHS Comparative Clinical Effectiveness Research Activities

November 20, 2020

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CONTACTS
Anne Berry, Lead Specialist, Implementation Research & Policy

The Government Accountability Office (GAO) released the Comparative Effectiveness Research: Patient-Centered Outcomes Research Institute and HHS Continue Activities and Plan New Efforts report on Nov. 18. The report presented results from a performance audit that found that the Patient-Centered Outcomes Research Institute (PCORI) and the Department of Health and Human Services (HHS) have continued to perform comparative clinical effectiveness research (CER) activities required by law since a prior report was issued in 2015.

Under a provision in both the Patient Protection and Affordable Care Act (P.L. 111-148)and the Further Consolidated Appropriations Act of 2020 (P.L. 116-94), the GAO is required to review the CER activities of PCORI, a federally-funded nonprofit corporation, and the HHS every five years to evaluate their effectiveness. In its review, the GAO reviewed program and expenditure data and other reports and documents, and it interviewed PCORI leadership, officials from the HHS, and representatives from nine stakeholder groups.

This performance audit found that between 2010 and 2019, PCORI and the HHS allocated approximately $3.6 billion for CER activities, the dissemination and implementation of research findings, and program support. During the same timeframe, PCORI funded 471 CER projects including primary research, observational studies, randomized clinical trials, and other methodologies. Additionally, the Agency for Healthcare Research and Quality established 11 CER training projects, conducted large-scale activities, and developed tools for disseminating CER activities, and the Assistant Secretary for Planning and Evaluation funded and supported 52 projects to build data capacity.

The report indicated that PCORI and the HHS have also planned to address new requirements. The Appropriations Act of 2020, which extended funding for CER activities and dissemination and implementation activities through 2029, requires PCORI to include research on intellectual and developmental disabilities and maternal mortality as research priority areas. It also mandates PCORI-funded research to take into consideration the full range of outcomes data, including considerations related to cost burdens and economic impact.

The GAO also found that “PCORI and HHS have taken steps to evaluate the effectiveness of their CER dissemination and implementation activities” and, as part of their strategic planning processes, plan to conduct comprehensive evaluations in the future.

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