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Medicare Modernization Act 2003
The Medicare Modernization Act of 2003 (MMA) launched a new era in national health policy in the United States. In addition to increasing access to outpatient prescription medications through a new federal program, this landmark legislation creates new opportunities and a renewed national interest in improving the quality, safety, and effectiveness of health care across all settings. The Part D drug benefit is in the forefront of this interest since the appropriate use of medications holds the potential to improve the health of many Americans as well as the effectiveness of nearly all other health care services in which pharmaceuticals are an integral component. Nevertheless, expanded access and use of drug therapies also holds the potential for poor outcomes resulting from the adverse drug effects of medications, suboptimal treatment response, inappropriate choice of therapy, and gaps in knowledge on the true effects of a therapy across all patient populations and conditions for which it is used. These results are especially true for treatments that over time are used in a broader spectrum of patients, clinical settings, and conditions than studied in pre-marketing clinical trials. Furthermore, pre-marketing studies are generally not designed to evaluate multiple endpoints, detect rare adverse effects, evaluate health outcomes over long periods, or compare all treatment options available to patients and their health care providers. As the federal government becomes a major payer of prescription drugs while also providing insurance coverage for hospital and medical care through Medicare, a new national focus has emerged on understanding the outcomes, effectiveness, and comparative effectiveness of treatments in clinical practice. This includes understanding the balance of risks and benefits for all forms of therapies as they are used beyond clinical research settings in routine clinical care.
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