An NIH study of treatments for high blood pressure, called the ALLHAT trial, shows some of the strengths and limitations of comparative effectiveness research to improve patient care. More...
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The House of Representatives passed their health reform package - the Affordable Health Care for America Act - last Saturday night by a vote of 220 to 215. With all of the provisions packed into the 2,000-page bill, what's in this historic legislation for comparative effectiveness research (CER)?
The main CER provision in the House health care bill - H.R. 3962 - is the creation of the Center for Comparative Effectiveness Research. Found in section 1401 of the legislation, this CER center will be established "within the Agency for Healthcare Research and Quality [AHRQ]...to conduct, support, and synthesize research (including research conducted or supported under section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003) with respect to the outcomes, effectiveness, and appropriateness of health care services and procedures in order to identify the manner in which diseases, disorders, and other health conditions can most effectively and appropriately be prevented, diagnosed, treated, and managed clinically."
Another CER provision is found in sub section 1181(b) of the bill. This section creates the Comparative Effectiveness Research Commission. The commission is tasked with advising "the [CER] Center and evaluat[ing] the activities carried out by the Center...to ensure such activities result in highly credible research and information resulting from such research."
While the House bill takes some steps to improve the independence of the CER Advisory Commission, it retains the same basic structure of a government-run research program. PIPC believes more work is needed to ensure the research effort is truly independent and patient-centered.
As the health care debate turns to the Senate, several senators have championed an independent institute, run outside government, which would govern future CER.
For example, Sens. Baucus (D-Mont.) and Conrad's (D-N.D.) bill - S. 1213 - sets up the Patient-Centered Outcomes Research Institute. Unlike the government-run CER center passed in the House bill, Sens. Baucus and Conrad's institute will "assist patients, clinicians, purchasers, and policy makers in making informed health decisions by advancing the quality and relevance of evidence concerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis that considers variations in patient subpopulations, and the dissemination of research findings with respect to the relative clinical outcomes, clinical effectiveness, and appropriateness of the medical treatments, services, and items described in subsection."
Quite simply, a non-governmental, independent institute is the right path for future CER. PIPC continues to work with policymakers and the public to ensure that any health care reform package with CER provisions that arrives on the president's desk provides for a transparent and private institute to usher in new CER efforts. Anything less will ultimately hurt patients for years to come.