The American Recovery and Reinvestment Act of 2009 (ARRA) provided $1.1 billion for major expansion of comparative effectiveness research (CER). This changing landscape of government research funding has caused federal agencies such as the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH), federal, state and local public health agencies, and also private organizations such as health insurance companies, health care delivery organizations, and pharmaceutical and device manufacturers, to organize themselves to conduct and disseminate comparative effectiveness research. This page provides an overview of some of the main funding sources for CER programs. Much of the information contained in the following sections was obtained from the publicly available website of the respective agencies and organizations.
Of the $1.1 billion of ARRA funds, AHRQ received $300 million and agreed to manage the $400 million allocated to the Office of the Secretary of the Department of Health and Human Services (HHS). The latter was established by ARRA to guide implementation of comparative effectiveness research, and was directed to contract with the Institute of Medicine (IOM) to develop national priorities for the new research. Additionally, $400 million was allocated to NIH.
Agency for Healthcare Quality (AHRQ)
AHRQ is using its $300 million of ARRA funds to expand and broaden existing activities through its Effective Health Care (EHC) program. These activities were initiated at the agency in response to the Medicare Prescription Drug, Improvement and Modernization Act of 2003. Proposals for funds focused initially on the fourteen priority conditions established by the Secretary of HHS under the 2003 Medicare Modernization Act, including (1) arthritis and nontraumatic joint disorders, (2) cancer, (3) cardiovascular disease, including stroke and hypertension, (4) dementia, including Alzheimer’s Disease, (5) depression and other mental health disorders, (6) developmental delays, attention-deficit hyperactivity disorder, and autism, (7) diabetes mellitus, (8) functional limitations and disability, (9) infectious diseases, including HIV/AIDS, (10 ) obesity, (11) peptic ulcer disease and dyspepsia, (12) pregnancy, including preterm birth, (13) pulmonary disease/ asthma, and (14) substance abuse. Priority was also given to research that focused on under-represented populations. To achieve the goals of producing patient-centered health research, AHRQ used a variety of funding mechanisms including grants, contracts, and inter-agency agreements. Award recipients included researchers, academic institutions, states, community-based organizations, national organizations, and Federal agencies. More information can be found on AHRQ’s website.
Developing Evidence to Inform Decisions about Effectiveness (DEcIDE and DEcIDE-2) Research Network
The DEcIDE Network is a collection of research centers that AHRQ created in 2005 as part of the Effective Health Care (EHC) Program. These centers will carry out accelerated studies, including research aimed at filling knowledge gaps about treatment effectiveness. Collectively, the DEcIDE centers will have access to de-identified medical data for millions of patients, including Medicare’s 42 million beneficiaries. Sebastian Schneeweiss, MD, ScD, vice chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women’s Hospital, Associate Professor of Medicine at the Harvard Medical School and Associate Professor of Epidemiology at the Harvard School of Public Health, leads one of the DEcIDE research centers.
The National Institutes of Health (NIH)
The NIH is the largest federal sponsor of clinical trials. With its $400 million of ARRA funding NIH aims to help stimulate the U.S. economy through the support and advancement of scientific research. While NIH Institutes and Centers have broad flexibility to invest in many types of grant programs, they will follow the spirit of ARRA by funding projects that will stimulate the economy, create or retain jobs, and have the potential for making scientific progress in two years. Funding mechanisms include: (1) select recently peer reviewed highly meritorious research grant applications (R01s and others), that can be accomplished in two years or less; (2) fund new research applications; (3) accelerate the tempo of ongoing science through targeted supplements to current grants; (4) support new types of activities such as the NIH Challenge Grant program that meet the goals of the Recovery Act; and (5) use other funding mechanisms as appropriate. For more information about NIH and recovery act grants visit their website.
The Patient-Centered Outcomes Research Institute (PCORI)
The Affordable Care Act created PCORI, a public-private non-profit entity that will fund CER. The institute is charged with: (1) establishing a research agenda, (2) developing research methodological standards, (3) contracting eligible entities to carry out the research, (4) ensuring transparency by requesting public input, and (5) disseminating the results to patients and healthcare providers. The only Harvard-based board member of PCORI is Arnold Epstein, MD, John H. Foster Professor and Chair of the Department of Health Policy and Management at the Harvard School of Public Health. Harvard-based members of the Methodology Committee are Sharon-Lise Normand, MSc, PhD, Professor of Health Care Policy at the Harvard Medical School and Professor of Biostatistics at the Harvard School of Public Health, and Sebastian Schneeweiss, MD, ScD, Associate Professor at the Department of Medicine at the Harvard Medical School and Associate Professor at the Department of Epidemiology at the Harvard School of Public Health.
Funding will be available from contributions from Medicare, private health insurers and self-insured health plans beginning at $1 per capita for FY 2013, rising to $2 per capita for FY 2014 (then indexed by the percentage increase in the projected per capita amount of National Health expenditures for FY 2015 through FY 2019). Additional financing is provided through appropriations, beginning with $10 million for FY 2010, rising to $150 million per year for FY 2012 through 2019.
A variety of entities are eligible to receive funding contracts, including federal agencies, academic institutions, and private research organizations. AHRQ and NIH will receive priority funding consideration. Data collected by the Centers for Medicare and Medicaid Services (CMS) will be made available to contracting research groups, and the institute may request data from other federal, state, and private entities hosting patient registries and other databases.
Regarding the priority setting process, the legislation states that the Institute “shall identify national priorities for research, taking into account disease incidence, prevalence, and burden in the US (with emphasis on chronic conditions), gaps in evidence in clinical outcomes, practice variations and health disparities in delivery and outcomes of care, the potential for new evidence to improve patient health, well-being, and the quality of care, the effect on national expenditures associated with a health care treatment, strategy, or health conditions, as well as patient needs, outcomes, and preferences, the relevance to patients and clinicians in making informed health decisions, and priorities in the National Strategy for quality care established under section 399H of the Public Health Service Act…..”
PCORI has released its first request for proposals (RFP) on October 31th, 2011. The solicitation addresses methodological standards for conducting patient-centered outcomes research. The RFP and other funding opportunities can be found on their website.