NHC Focus on: PCORI Reauthorization

Monday, September 30, 2019

By Jennifer Dexter, Director, Policy

The Patient-Centered Outcomes Research Institute (PCORI) is a private, non-profit and tax-exempt organization that is tasked with coordinating and supporting comparative clinical effectiveness research (CER).

PCORI funds research that not only engages patients throughout the research process, but also incorporates patient input into research design with the goal of studying the outcomes that matter most to patients. In order to capture health care solutions that are both evidence-based and patient-centered, PCORI funds CER studies that help determine which treatment approaches are best for which patients.

The Affordable Care Act (ACA) designated annual funding for PCORI until the end of FY2019. PCORI is funded by the Patient-Centered Outcomes Trust Fund (Trust Fund), which was also established by the ACA. The Trust Fund is funded through annual appropriations, fees on health insurance and self-insured plans, and transfers from Medicare Part A and Part B trust funds. Eighty percent of the Trust Fund is required by the ACA to go to PCORI for funding research and operational costs while the remaining twenty percent is transferred to the Department of Health and Human Services, including the Agency for Healthcare Research and Quality (ARHQ) for disseminating research findings and research capacity building.  

PCORI was authorized for 10 years, and unless Congress acts, funding for PCORI is scheduled to end on November 21, 2019. It is unlikely that reauthorization will occur before funding ceases, but PCORI will continue to operate and fund ongoing research. The House Ways & Means Committee passed the Protecting Patients Access to Information for Effective and Necessary Treatment and Services (PATIENTS) Act of 2019 in June 2019. The PATIENTS Act would reauthorize PCORI for seven years and make minor changes to PCORI's national research priorities to include substance abuse and mental and materna health. The House Energy & Commerce Committee also passed the Community Health Investment, Modernization and Excellence Act of 2019 to reauthorize PCORI for three years with no policy changes. The Senate has yet to release a bill to reauthorize PCORI, but it is expected that their version will have more policy changes than the House, perhaps regarding PCORI’s governing board. It is expected that the Senate bill, which is being crafted in a bipartisan basis, will ultimately be the bill that both chambers vote on before sending to the President’s desk.

NHC Recommendations for PCORI Reauthorization

In July, the NHC and FasterCures published an op-ed in The Hill outlining the importance of PCORI reauthorization. Additional, the NHC Board of Directors approved Domains & Values to guide our policy making for PCORI Reauthorization. The NHC has asked for the following to optimize PCORI Reauthorization:

  • Continue to focus on patient involvement;
              -    Ensure that patients have at least the same level of representation on the Board and other governance bodies;
              -    Continue requiring patient partnership in research;
              -    Continue to hold workshops and engagement events aimed at gathering patient stakeholder priorities and input;
 
  • Include preamble or report language directing incremental changes to enhance impact and relevance to patients;
              -     Encourage research that assesses treatment value from the patient and family perspective;
              -     Increase patient input and transparency in the selection of national priority topics and research questions;
              -     Expand funding mechanisms that support patient-driven research;
              -     Increase emphasis on building patient capacity to engage in PCOR activities;
 
  • Avoid substantial changes that would negatively impact patients or decrease the likelihood of reauthorization;
             -      Continue the ban on conducting cost-effectiveness research; and
             -      Continue the ban on using research to drive Medicare national coverage decisions.
 

We will use these principles to evaluate the Senate bill when it is released. For more information, please contact NHC Vice President, Policy & Government Affairs Eric Gascho.