Health Care Reform and a CER Entity: Will It Happen?

In January 2009, it appeared to be nearly certain that Congress would approve a health care reform bill that included provisions to establish a comparative effectiveness research (CER) entity. It’s now one year later, and health care reform is looking more uncertain, with the House and Senate mired in debate over differences between their bills and challenged by a newly elected Republican Senator who has pledged to vote against the current reform bill. If an agreement is reached, it is still likely that a new CER entity will remain a key element – alternatively, if an agreement is not reached on comprehensive reform, CER legislation may move forward separately. The bigger questions, then, are how would the entity be structured and how would the research and information be disseminated?

The main, and perhaps most important, difference between the current House and Senate bills is the location of the CER entity. The Senate bill would establish a non-profit corporation, called the “Patient-Centered Outcomes Research Institute,” outside of the federal government. Oversight of the Institute would be conducted by an independent, 19-member multi-stakeholder Board of Governors that includes the director of Agency for Healthcare Research and Quality (AHRQ) and director of the National Institutes of Health (NIH), with the remaining members appointed by the U.S. Comptroller General. By contrast, the House proposal would establish a “Center for Comparative Effectiveness Research” within AHRQ. An advisory commission would oversee and evaluate the Center’s activities. Both bills, however, would fund the CER entity through mandatory, multi-year funding from public and private sources and would create a trust fund to receive public and private payer contributions.

Under both bills, the entity could contract with private and governmental entities to conduct research and the research would be required to take into account the potential for various treatments to have different degrees of effectiveness among subpopulations. The research supported or conducted by the entity must be transparent, credible, and accessible to the public.

Whether the CER entity is public or private, AHRQ can be expected to continue to play a major role, particularly in setting standards and developing appropriate methods for CER, as well as in its dissemination to the public. Under the House scenario, research dissemination and methods and procedures would be developed by AHRQ; under the Senate version, the responsibility for translation and dissemination of findings is transferred to the Office of Communication and Knowledge Transfer in AHRQ, in consultation with the National Institutes of Health. The explanation of findings would include a description of considerations for specific subpopulations, the research methodology used, and the limitations of the research.

Outside of the entity’s location, the two bills are not that far apart on CER, which should make it easier for House and Senate negotiators to find common ground on this particular issue. But if legislation is scuttled, it’s unclear what will happen with CER after the $1.1 billion allocated by the American Recovery and Reinvestment Act (ARRA) is exhausted. Certainly, AHRQ will continue to take the lead on ARRA-funded studies, as well as CER conducted in the “Effective Healthcare Program” that was developed under authority granted to AHRQ under Sec. 1013 of the Medicare Modernization Act in 2003. Without either comprehensive health care reform legislation or standalone enactment of a new Comparative Effectiveness Research “Institute,” it is unclear if Congress will appropriate funds beyond AHRQ’s existing budget for CER. Despite the uncertainty in how government will move forward, it is important to note that there remains considerable interest in CER in both the public and private sector. It will, therefore be important to continue to support well-designed CER, which can greatly benefit patients and help to “inform” health care providers as they, together with their patients, use evidence to make decisions regarding the best treatment choices.