Baucus, Conrad introduce bill to fund comparative effectiveness institute
 Sen. Max Baucus, D-Mont.
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Senate Finance Committee Chairman Max Baucus, D-Mont., and Senate Budget Committee Chairman Kent Conrad, D-N.D., introduced legislation to establish a private, nonprofit corporation that will research and compare clinical outcomes of alternative therapies and health strategies.

"Investing in research on best practices will drive down healthcare costs over the long run and will be an essential part of our effort to overhaul the health care system this year," Baucus said.

The Baucus-Conrad bill, The Patient-Centered Outcomes Research Act of 2009, would establish the Patient-Centered Outcomes Research Institute to generate evidence and information on diseases, disorders and other health conditions in order to acheive the best clinical outcomes.

Providing patients and doctors with more unbiased data on the effectiveness of the treatments available to them would reduce the rate of growth in healthcare costs, according to the Congressional Budget Office (CBO). The senators said that an increased focus on healthcare research is expected to play a role in healthcare reform legislation expected to be considered in the Finance Committee this month.

According to the drafters, the Institute will research treatments, including surgical procedures, pharmaceuticals, medical devices and other measures. Research will be conducted by public and private organizations approved by the Institute's board of directors, which would include practicing doctors, patients, pharmaceutical and biotechnology vendors.

Baucus and Conrad introduced similar legislation in the 110th Congress. However, the 2009 legislation requires the Centers for Medicare and Medicaid Services (CMS) to meet several requirements before allowing the use of any research, including gathering data from comparative effectiveness studies, in making coverage decisions. This process includes allowing stakeholders and other individuals the opportunity to provide input and comment on draft proposals, incorporating relevant findings and evidence, in addition to comparative effectiveness research, and considering the impacts on patient subpopulations.

The senators summarized the Act:
Finding Out What Works in Health Care: Establish a private, nonprofit corporation, called the Patient-Centered Outcomes Research Institute, that generates evidence through a transparent process on which healthcare interventions and services work. Comparative effectiveness research compares clinical outcomes, or effectiveness, of alternative therapies and health strategies for the same condition. The goal is to provide better evidence, so doctors and patients can make informed decisions. 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 understand. The Institute will be governed by a multi-stakeholder board of governors, including the Secretary of Health and Human Services (HHS), the directors of AHRQ and the National Institutes of Health (NIH), and 18 additional members representing diverse public and private sector expertise and interests. The members will be appointed by the U.S. Comptroller General.

Ensuring Credible and Objective Research: Develop the field of comparative effectiveness research. To accomplish this, the bill requires the institute to establish an expert methodology committee to develop the standards to be used in the conduct of the institute's research. Research conducted through the Institute will be subject to public comment periods or a peer-review process. The methodology committee is charged to work with the Institutes of Medicine to examine whether scientifically valid methods exist to assess aspects of the healthcare delivery system, such as benefit design, and efficiency and value in comparative effectiveness research. Furthermore, the Institute's placement outside of the government will attempt to ensure that political influence is minimized, along with regular reviews by the Government Accountability Office (GAO).

Transparency and Public Input: The Institute will continuously seek input from stakeholder, and establish expert advisory panels to make certain that its research and findings are relevant to decision-makers at the point of service. In the case of primary research or rare disease studies, 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 will be encouraged to design research that looks at differences in clinical outcomes among patient subpopulations, such as racial and ethnic minorities. The Institute also will be 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 payors, 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.