Did the Medicare Modernization Act Cause Oncology Drug Shortages

医疗保险现代化法案是否导致肿瘤药物短缺

• 批准号: 8761859
• 负责人: Mireille Jacobson
• 金额: $ 67.14万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-30 至 2018-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8761859
• 关键词: Did; Medicare; Modernization; Act; Cause

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.

描述（由申请人提供）：自2006年以来，美国的处方药短缺数量与无菌注射药物（如肿瘤药物）的数量显着增加，占2011年这些短缺的70％以上（Aspe 2011）。众多专家坚持认为，最近肿瘤学药物短缺的升高最终是由于经济因素，具体来说，是《医疗保险药物改进和现代化法》（MMA）的规定，该法案（MMA）大大降低了许多医师管理（B Part-B）药物（包括化学治疗剂，包括在2005年的研究）的直接疗法（包括直接效力）的医学疗法（包括Part-B）的药物（包括）。 MMA如何与其他因素相互作用，例如专利到期和FDA执法，以产生短缺（AIM 2）；以及MMA可能会产生药物短缺的机制，包括肿瘤学实践和制造商合并（AIM 3）。尽管正在进行的政策努力试图解决短缺的近端原因，例如，对FDA的早期警告并加快额外挽救生命的药物的批准，但对药物短缺问题的持久解决方案必须解决基本原因，尤其是，尤其是由MMA等政策产生的经济奖励的作用。