Introduction: Medicare Section 1013 and AHRQ's Effective Health Care Program.

Objective: To introduce Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 and the Agency for Healthcare Research and Quality's (AHRQ) Effective Health Care Program.

Background: AHRQ, under Section 1013 of the MMA of 2003, has been charged with conducting specific health care outcomes studies through the Effective Health Care Program. This research is aimed specifically at determining the safety and effectiveness of certain pharmaceuticals since comparative data is currently lacking. Highly utilized, high-cost (or both) treatments are the focus of the studies that will be conducted through AHRQ's Evidence-based Practice Centers (EPCs) and the Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Network. Current and completed projects are noted, including more detailed information on the reviews pertaining to treatment of rheumatoid arthritis with nonbiologic disease-modifying antirheumatic drugs (DMARDs) and biologics (anti-tumor necrosis factor [TNF]-alpha therapies).

Summary: AHRQ's EPCs and the DEcIDE Network are studying safety and the comparative effectiveness of a number of different pharmaceutical-related topics, including the safety and effectiveness of biologic and nonbiologic DMARDS (e.g., TNF antagonists). The final reports, once complete, will be translated (explained in terms that can be more easily understood by all decision makers) and then disseminated to all stakeholders.