Did the Medicare Modernization Act Cause Oncology Drug Shortages

描述（由申请人提供）：自2006年以来，美国经历了处方药短缺数量的显著增加-无菌注射药物，如肿瘤药物，占2011年这些短缺的70%以上（ASPE 2011）。许多专家坚持认为，最近肿瘤药物短缺的增加最终是由于经济因素，特别是医疗保险药物改进和现代化法案（MMA）的一项规定，该法案从2005年开始大幅减少了许多医生管理的（部分b）药物（包括化疗药物）的医疗保险报销。拟议的研究将检查MMA对肿瘤药物短缺的直接和长期影响（目标1）；MMA如何与其他因素相互作用，如专利到期和FDA执法，产生短缺（目标2）；以及MMA可能导致药物短缺的机制，包括肿瘤学实践和制造商整合（目标3）。虽然正在进行的政策努力试图解决短缺的近因，例如，向FDA发出早期预警，加快批准替代救生药物，但药物短缺问题的持久解决方案必须解决根本原因——特别是，由MMA等政策创造的经济激励作用。

DESCRIPTION (provided by applicant): Since 2006, the U.S. has experienced a marked increase in the number of prescription drug shortages-with sterile injectable drugs, like oncology drugs, accounting for more than 70% of these shortages in 2011 (ASPE 2011). Numerous experts maintain that the recent rise in oncology drug shortages is due ultimately to economic factors and, specifically, a provision of the Medicare Drug Improvement and Modernization Act (MMA) that substantially reduced Medicare reimbursement for many physician-administered (Part-B) drugs, including chemotherapy agents, beginning in 2005. The proposed study will examine the direct and long run effects of the MMA on oncology drug shortages (Aim 1); how the MMA may interact with other factors, such as patent expirations and FDA enforcement, to generate shortages (Aim 2); and the mechanisms through which the MMA could have generated drug shortages, including oncology practice and manufacturer consolidation (Aim 3). While ongoing policy efforts try to address the proximal causes of shortages through, for example, early warnings to the FDA and expedited approval of alternative life-saving medications, a lasting solution to the drug shortage problem must address the fundamental causes - particularly, the role of economic incentives created by policies such as the MMA.