WASHINGTON – Today, U.S. Sens. Mark R. Warner (D-VA), Bill Cassidy (R-LA), Chris Van Hollen (D-MD) and Shelley Moore Capito (R-WV) introduced bipartisan legislation to reauthorize the independent nonprofit corporation established to save Americans money on their health care costs and help patients better understand their diagnostic and treatment options. The Patient-Centered Outcomes Research Institute (PCORI) helps inform health care decisions by providing evidence on the effectiveness, benefits and harms of different treatment options for a condition.

“As medical care and innovation continues to advance, patients have a right to know whether their particular treatment is effective, or whether a different course of action might work better for them,” said Sen. Warner. “Frankly, nobody wants to spend time or money on a procedure they don’t need, but too often, folks don’t have the information they need to make that determination. That’s why I’m proud to introduce this legislation today to help make sure that this crucial institute can continue its work of providing patients and their health care providers with an independent look at their options.” 

“One-size-fits-all medicine does not work. Patients deserve effective and efficient care tailored to them,” said Dr. Cassidy. “Health care costs are lowered when patients have information and can choose what is right for them.”

“This innovative Institute was created to provide patients with the high-quality information they need to make better-informed decisions about their health care. Their work is producing more reliable research to guide health care decisions that increasingly rely on personalized diagnosis and treatments,” said Sen. Van Hollen. “This bill provides the roadmap for the next ten years so they can conduct cutting edge research to improve patient outcomes and save lives.”

“In making health care decisions, it is essential patients have as much useful information as possible,” Sen. Capito said. “PCORI allows patients and their families to compare different treatment options, their effectiveness, and their costs to make more informed decisions. This hopefully helps them not only improve their care, but also spend limited health care dollars more wisely.”

PCORI is an independent nonprofit tasked with examining the relative health outcomes, clinical effectiveness and appropriateness of different medical treatments. Findings from PCORI funded studies are made public so that patients, health care providers and payers can use this information to improve patient care and reduce their health costs. PCORI funded research does not determine coverage or reimbursement decisions at the Centers for Medicare and Medicaid Services (CMS), but CMS can consider PCORI’s research alongside other factors and public input when deciding what procedures it will cover.

Since 2012, PCORI has approved more than $2.3 billion in grants to advance research on patient-centered outcomes. Since PCORI’s authorization, several studies have contributed to significant changes in decision-making and healthcare spending, including helping reduce patient out-of-pocket costs, health spending on unneeded care, unnecessary hospital stays and intensive medical tests. Additionally, research by PCORI has helped to better inform physicians and patients on a broad array of treatments, including opioid prescribing and substance use disorder treatments, obesity weight loss surgery, telehealth use and more. 

The bipartisan Senate legislation would extend PCORI’s funding through FY2029. The bill would also:

Ensure PCORI conducts additional research on rising health care costs by directing researchers to collect data on the potential burdens and economic impacts of the utilization of medical treatments, items and services on different stakeholders and decision-makers. These potential burdens and economic impacts include medical out-of-pocket costs, non-medical costs to the patient and family, effects on future costs of care, workplace productivity and absenteeism and healthcare utilization.

Establish an ‘Expert Advisory Panel for High-Impact Research’ to assist and advise PCORI on ways to better take into account and target diseases, conditions and care interventions that have a high-impact on national health spending.

Improve PCORI’s ability to study the relative cost and effectiveness of prescription drugs, medical devices and other health care interventions by ensuring appropriate patient coverage for PCORI funded clinical trials and studies. The legislation also requires the Government Accountability Office (GAO) to report on remaining barriers to conducting clinical trials and studies.

Direct PCORI to maintain its commitment to robust and meaningful patient engagement, including in the selection of national priority topics and research questions.

Strongly encourage PCORI and AHRQ to maintain their commitment to disseminating and implementing research findings and provide strategies to facilitate the adoption of PCORI-funded research into practice.

“We applaud the introduction of this important piece of legislation to reauthorize the Patient-Centered Outcomes Research institute (PCORI). Continuing their existing funding streams for ten years will ensure that PCORI can continue its vital work producing information patients need to decide the care that is best for them.  We particularly support the emphasis on strengthening the way PCORI engages patients and patient organizations and guidance on using a wide variety of outcomes data to ensure patients’ needs are considered in research,” said Marc Boutin, JD, Chief Executive Officer, National Health Council.

“At the University of Virginia School of Medicine, PCORI is funding projects in rural and underserved areas, including studies intended to reduce cancer disparities in rural Appalachian communities and to compare childhood obesity treatments in the Dan River region. Such work is critical to finding effective health care solutions in these communities. The Patient-Centered Outcomes Research Institute Reauthorization Act will ensure that invaluable health care information and its scientific findings can continue to be generated and disseminated to patients and providers, allowing them to make needed decisions to choose the best treatments,” said Dr. David S. Wilkes, M.D., Dean of the University of Virginia School of Medicine.

“I am grateful for the leadership of Sens. Warner, Cassidy, Van Hollen, and Capito in introducing this legislation,” said Dr. Peter Buckley, M.D., Dean, Virginia Commonwealth University (VCU) School of Medicine, and Executive Vice President for Medical Affairs, VCU Health System. “The Patient-Centered Outcomes Research Institute (PCORI) is a critical, independent funder of research that is truly patient-centered – a key value of the VCU Health System. Reauthorizing PCORI for another ten years and maintaining its unique funding mechanism will ensure continued advances in care and our understanding of what works – and for whom – when it comes to treating disease.”

“PCORI has changed how clinical research is conducted at Johns Hopkins and throughout the United States. Through research networks created by PCORI and standalone studies funded by PCORI, the power of including patients in the design, conduct, and analysis of the studies has been demonstrated multiple times. PCORI-funded studies evaluate the concerns of patients directly important to them and provide the evidence we all need to make better decisions about treatment options. Reauthorization of PCORI will provide the evidence American needs in the next decade to create a health system that delivers effective, patient-centered, and high-value care,” said Dr. Daniel Ford, M.D., M.P.H., Vice Dean for Clinical Investigation, Johns Hopkins School of Medicine.  

The text of this legislation is available here. 

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