For all the advances it produces, traditional research does not always address the questions patients face daily about which care approaches work best in their particular situations. PCORI is the only organization dedicated to funding studies comparing which care approaches work best, for whom, under which circumstances. And PCORI is the only research funder guided by input from patients. PCORI requires its contracted researchers to engage patients and other stakeholders throughout the research process so the studies produce useful information.
For example, PCORI is funding a randomized study of oral regimens for hepatitis C looking at treatment impact in real world conditions on a diverse population and measuring outcomes that patients and stakeholders identified as being most important when making treatment decisions. Another study compares the outcomes of drugs versus appendectomy. PCORI has also completed research comparing stroke patients treated with warfarin versus those not treated with any oral anticoagulant at discharge from the hospital, determining directly from stroke survivors the outcomes that mattered most to them. Recognizing the burden of mental illness, PCORI supports several projects focused on helping individuals and communities to identify and address mental health problems across the spectrum of treatment options and care delivery. Consistent with the drive toward personalized medicine, PCORI has funded 124 CER studies that have a significant shared-decision-making component on a wide range of conditions, including cancer, cardiovascular disease, mental and behavioral health, and multiple chronic conditions.
Additionally, PCORI is building an infrastructure to support patient-centered CER. Most prominently, the National Patient-Centered Clinical Research Network (PCORnet) is a large national network for conducting CER through partnerships with patient organizations and large clinical networks, making it highly representative of a diverse population of patients. PCORnet fosters a range of observational and experimental CER by establishing a resource of clinical data gathered in a variety of healthcare settings, including hospitals, doctors' offices and community clinics.
How is PCORI Funded?
PCORI is funded through the Patient-Centered Outcomes Research Trust Fund (PCOR Trust Fund), which receives income from three funding streams: appropriations from the general fund of the Treasury, transfers from the Centers for Medicare and Medicaid (CMS) trust funds, and a fee assessed on private insurance and self-insured health plans (the PCOR fee). The bulk of PCORI’s funds come from the PCOR fee ($252 million in 2016, $210 million in 2015). The PCOR fee in FY 2013 was $1 per covered individual, increasing to $2 per covered individual as of 2014. In each fiscal year thereafter through 2019, the fee is adjusted for increases in healthcare spending. (The fee was revised in April 2017 to $2.26 per covered person.) For FYs 2013 through 2019, the PCOR Trust Fund will receive $150 million from the general fund annually.
Reauthorization in 2019
PCORI’s current authorization will expire September 30, 2019. At that point, PCORI will no longer have the authority to commit to new research grants, and only previously-awarded grants will continue to be funded. As detailed in projections at a PCORI Board of Governors Meeting, PCORI’s research commitments are expected to support research expenses through FY 2023, while funding for new research commitments and infrastructure (PCORnet) will lapse without Congressional action.