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(申请人提供)：自2006年以来，美国处方药短缺的数量显著增加-2011年，无菌注射类药物，如肿瘤学药物，占短缺的70%以上(ASPE 2011)。许多专家认为，最近肿瘤学药物短缺的增加最终是由于经济因素，特别是《联邦医疗保险药物改进和现代化法案》(MMA)的一项条款，该条款从2005年开始大幅减少了包括化疗药物在内的许多医生管理的(B部分)药物的医疗保险报销。拟议的研究将审查MMA对肿瘤学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的执行，以产生短缺(目标2)；以及MMA可能造成药物短缺的机制，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通过例如向FDA发出早期警告和加快批准替代救命药物来解决短缺的近端原因，但药品短缺问题的持久解决方案必须解决根本原因--特别是MMA等政策创造的经济激励的作用。