Senate Introduction of Comparative Effectiveness Research Legislation
On June 9, 2009 U.S. Senate Finance Committee Chairman Max Baucus (D-MT) and Senate Budget Committee Chairman Kent Conrad (D-ND) introduced the "Patient-Centered Outcomes Research Act of 2009" (S. 1213) to improve the quality of health care that Americans receive by ensuring doctors and patients have the best possible research and information on the effectiveness of different health care treatments. The Heart Rhythm Society is currently analyzing the legislation to determine its impact on EP practices.
This legislation establishes a private, nonprofit corporation, the Patient-Centered Outcomes Research Institute, to provide for the generation and synthesis of comparative clinical evidence of which health care interventions and services work and which ones don’t. This type of research compares clinical outcomes, or the “clinical effectiveness,” of alternative therapies and health strategies for the same condition. The goal of the research is to provide better evidence — objective information — so doctors and patients can make informed health decisions.
Among the duties of thePatient-Centered Outcomes Research Institute are:
- establish a objective research agenda
- develop research methodological standards
- contract with eligible entities to conduct the research
- ensure transparency by requesting public input
- dissiminate the results to patients and healthcare providers
Establishing the Priorities Agenda
The Institute will establish a national agenda of research priorities, based on the need for better evidence, disease burden, practice variations, the potential for improved care, and expenditures associated with a given health condition or care strategy.
The Institute can contract with federal agencies, such as the Agency for Healthcare Research and Quality (AHRQ), and appropriate private entities to conduct the research, which will include both systematic reviews and primary research.
Research findings will be publicly disseminated in ways patients and healthcare providers can easily understand. The Institute will be governed by a multi-stakeholder Board of Governors, including 18 members (appointed by the Comptroller General of the U.S.) who represent diverse public and private sector expertise and interests. Members will also include the Secretary of Health and Human Services, the Directors of AHRQ and the National Institutes of Health.
A critical component of the Institute’s mission is to develop the field of comparative effectiveness research (CER). To accomplish this, the bill requires the Institute to establish an expert methodology committee that is charged with developing the standards which must be used in the conduct of the Institute’s research. To ensure adherence to these methodological standards and to principles of scientific integrity, all research conducted through the Institute will be subject to public comment periods or a peer-review process.
The methodology committee is also charged to work with the Institutes of Medicine to examine whether scientifically valid methods exist to assess aspects of the health care delivery system (such as benefit design) and efficiency and value in comparative effectiveness research. The Institute’s placement outside of the government ensures that undue political influence is minimized, while regular reviews by the Government Accountability Office ensures accountability.
Ensuring Transparency
The Patient-Centered Outcomes Research Institute will seek input from a broad array of stakeholders on a continuous basis throughout its activities, ensuring that its research is relevant to the needs of patients, physicians, and other stakeholders and that the research is disseminated in ways most useful to health care decision-makers. The Institute will establish expert advisory panels to make certain that its research and findings are relevant to decision-makers. In the case of primary research or rare disease studies, relevant expert advisory panels will be convened to provide guidance on the research question, study design and structure as well as technical support. Furthermore, the Institute is encouraged to design research that looks at differences in clinical outcomes among patient subpopulations, such as racial and ethnic minorities, because their response to medical treatments may vary. The Institute is also required to establish formal public comment periods regarding many of its activities and to host forums for public input. Ultimately, the Institute will disseminate research findings, but will be prohibited from issuing practice or policy recommendations or coverage guidelines.
Funding
The Institute and its activities will be funded by contributions from both public and private payers, made available to the Institute through a Patient-Centered Outcomes Research Trust Fund (PCORTF). Contributions to the PCORTF will include general revenues, amounts from the Medicare Trust Funds phased-in to $2 per beneficiary annually, and amounts from a $2 fee per-covered-life assessed annually on insured and self-insured health plans.
Five years after enactment, total annual funding for the Institute will reach nearly $600 million, with the Medicare Trust Fund transfer and annual fee on insured and self-insured plans not taking effect until 2013.
