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Overview of the Patient-Centered Outcomes Research Institute
The Patient Protection and Affordable Care Act, the health reform bill recently signed into law by President Obama, establishes a private, non-profit entity called the Patient-Centered Outcomes Research Institute. The Institute will spearhead efforts to prioritize and fund comparative effectiveness research (CER) using a largely stakeholder-driven process. This initiative builds upon the strong foundation laid in 2009 by the $1.1 billion in funding for CER in the American Recovery and Reinvestment Act (ARRA).
Duties and Authority
The Institute will establish and execute a national CER agenda by identifying research priorities and funding and facilitating new CER studies. These studies will consist of both systematic reviews of existing evidence and new prospective research, including clinical trials and observational studies.
The specific duties of the Institute are to:
- Establish an objective research agenda;
- Develop research methodological standards;
- Contract with eligible entities to conduct the research;
- Ensure transparency by requesting public input; and
- Disseminate the results to patients and healthcare providers.
A variety of entities are eligible to receive funding
contracts, including federal agencies, academic institutions, and private
research organizations. The Agency for Healthcare Research and Quality (AHRQ) and
the National Institutes of Health (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.
The Institute will emulate the peer-review processes of the NIH and
AHRQ.
Development of CER Methods
A standing methodology committee will lead efforts to identify and refine methodological standards for different types of CER study designs, such as pragmatic clinical trials, randomized controlled trials, and patient registries. The 15-member committee will be composed of experts in comparative effectiveness methods, biostatisticians, epidemiologists, health services researchers, and other experts. The committee must begin releasing methodological standards for conducting CER within 18 months of the establishment of the Institute. These standards will be used to select proposed studies for funding and to guide researchers as they design trials. In addition, the committee will develop tools to help researchers determine which methods are most appropriate for a particular research question.
Stakeholder Involvement and Transparency
The Institute will form a number of internal advisory panels to set research priorities and oversee clinical trials. These panels will include practicing clinicians, patient and consumer representatives, clinical and health services researchers, payers, manufacturers, and others. Notably, the health reform bill requires the Institute to provide patients and consumers with the extra support, tools, and resources necessary to be effective members of these advisory panels. In addition, there will be public comment periods to allow the general public to provide feedback to the Institute on proposed priorities and other key decisions, in an effort to make the work of the Institute and advisory panels as transparent as possible.
Dissemination and Use of Research Findings
The law allows CMS to use CER evidence in coverage and/or reimbursement decisions as long as the coverage process is an iterative one—a standard that the current CMS national coverage determination process meets. CMS may also use CER to establish differential copayments, which could be used in a value-based insurance design program. The bill specifically prohibits any cost-effectiveness analysis that would use any adjusted life years factor that would place lower value on the life of elderly, disabled, or terminally ill individuals compared to younger and healthier individuals.
Research findings must be released to the general public no later than 90 days after they are available. The Office of Communications and Knowledge Transfer at AHRQ will facilitate the wide dissemination of findings, with assistance from NIH. This will include consultation with medical and clinical associations to ensure that findings are translated into clinical decision support tools.
Staffing and Governance
The Institute will have an internal staff led by an executive director and will utilize outside experts and consultants. In addition, the Institute will be guided a Board of Governors, which will include the directors of NIH and AHRQ, patient advocates, consumer representatives, physicians, nurses, hospitals, private payers, drug and device industries, quality improvement organizations, and other federal and state health agencies. The Comptroller of the United States will appoint members to the Board for six year terms and will designate a chair and vice chair.
Funding
The Institute will be funded through the Patient-Centered Outcomes Research Trust Fund (PCORTF), which will consist of funding streams from general revenues, an annual $2 fee per Medicare beneficiary transferred from the Medicare Trust Fund, and an annual $2 fee per-covered-life assessed on private health plans. The annual fee on insured and self insured plans takes effect in 2012. By 2015, total annual funding for the Institute will reach nearly $500 million.
