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Congress and Issues Regarding Specialty Pharmaceuticals
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It is expected that you will provide a focused topic that identifies a problem/issue of concern and the legislation that is/has/will address the problem. Once you have identified your legislation, you will not be allowed to change. Complete some preliminary research to ensure that you have enough sources and information available to meet both the page length and number of source requirements.
Topics such as HIPAA and Medicare (for example) are too broad for this assignment. You need to focus your topic on a specific aspect, such as the Privacy Rules of HIPAA or the Medicare Prescription Drug Benefit.
Topic 1
OUTLINE TITLE
I. Specialty Pharmaceuticals
II. Legislation/policy analysis
A. Specialty Tiers.
B. Cost Sharing Burden.
III. Problem/issue addressed
A. Biosimilar Medications.
B. Generic Medications.
IV. History of the legislation
A. Drug Importation Act of 1848
B. Biologics Control Act of 1902.C. Pure Foods and Drug Act of 1906.
D. Harrison Narcotic Act of 1914.E. Food, Drug, and Cosmetic Act of 1938……
