Clinical and Population Health Research Program, Graduate School of Biomedical Sciences, University of Massachusetts Medical School, Worcester, MA 01655, USA.
Drugs Aging. 2013 Sep;30(9):701-20. doi: 10.1007/s40266-013-0096-6.
In the largest overhaul to Medicare since its creation in 1965, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 established Part D in 2006 to improve access to essential medication among disabled and older Americans. Despite previous evidence of a positive impact on the general Medicare population, Part D's overall effects on long-term care (LTC) are unknown.
The purpose of this systematic review was to evaluate the literature regarding Part D's impact on the LTC context, specifically costs to LTC residents, providers and payers; prescription drug coverage and utilization; and clinical and administrative outcomes.
Four electronic databases [PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Health Business Fulltext Elite and Science Citation Index Expanded], selected US government and non-profit websites, and bibliographies were searched for quantitative and qualitative studies characterizing Part D in the LTC context. Searches were limited to studies that may have been published between 1 January 2006 (date of Part D implementation) and 8 January 2013.
Systematic searches identified 1,624 publications for a three-stage (title, abstract and full-text) review. Included publications were in English language; based in the US; assessed Part D-related outcomes; and included or were directly relevant to LTC residents or settings. News articles, reviews, opinion pieces, letters or commentaries; case reports or case series; simulation or modeling studies; and summaries that did not report original data were excluded.
A standardized form was used to abstract study type, study design, LTC setting, sources of data, method of data collection, time periods assessed, unit of observation, outcomes and results. Methodological quality was assessed using modified criteria specific to quantitative and qualitative studies.
Eleven quantitative and eight qualitative studies met inclusion criteria. In the seven years since its implementation, Part D decreased out-of-pocket costs among enrolled nursing home residents and potentially increased costs borne by LTC facilities. Coverage of prescription drugs frequently used by older adults was adequate, except for certain drugs and alternative formulations of importance to LTC residents. The use of medications that raise safety concerns was decreased, but overall drug utilization may have been unaffected. Although there was uncertain impact on clinical outcomes, quantitative studies demonstrated evidence of unintended health consequences. Qualitative studies consistently revealed increased administrative burden among providers.
Empirical evidence of Part D's LTC impact was sparse. Due to limitations in available types of data, quantitative studies were generically lacking in methodological rigor. Qualitative studies suffered from lack of clarity of reporting. As future studies use clinical Medicare data, study quality is expected to improve.
Although LTC-specific policies continue to evolve, it appears that the prescription drug benefit may require further modifications to more effectively provide for LTC residents' unique medication needs and improve their health outcomes. Adjustments may be needed for Part D to be more compatible with LTC prescription drug delivery processes.
自 1965 年医疗保险创立以来，2003 年的《医疗保险处方药改进和现代化法案》是对医疗保险的最大改革，该法案于 2006 年设立了 Part D，旨在改善残疾人和美国老年人获得基本药物的途径。尽管先前有证据表明对一般医疗保险人群有积极影响，但 Part D 对长期护理（LTC）的总体影响尚不清楚。
本系统评价的目的是评估文献中关于 Part D 对 LTC 环境的影响，特别是对 LTC 居民、提供者和支付者的长期护理成本；处方药物的覆盖范围和使用情况；以及临床和行政结果。
四个电子数据库（PubMed、Cumulative Index to Nursing and Allied Health Literature（CINAHL）、Health Business Fulltext Elite 和 Science Citation Index Expanded），选定的美国政府和非营利性网站，以及参考书目，均对在 LTC 环境中评估 Part D 的定量和定性研究进行了搜索。搜索仅限于可能于 2006 年 1 月 1 日（Part D 实施日期）至 2013 年 1 月 8 日期间发表的研究。
系统搜索确定了 1624 篇出版物，进行了三阶段（标题、摘要和全文）审查。纳入的出版物为英文；基于美国；评估与 Part D 相关的结果；并包括或直接与 LTC 居民或环境相关。排除新闻文章、评论、意见文章、信件或评论；病例报告或病例系列；模拟或建模研究；以及未报告原始数据的摘要。
使用标准化表格提取研究类型、研究设计、LTC 环境、数据来源、数据收集方法、评估时间段、观察单位、结果。使用针对定量和定性研究的特定修改标准评估方法学质量。
符合纳入标准的有 11 项定量研究和 8 项定性研究。自实施以来的七年中，Part D 降低了登记在护理院居民的自付费用，并且可能增加了 LTC 设施的成本。老年人经常使用的处方药的覆盖范围充足，但对于某些对 LTC 居民重要的药物和替代制剂除外。引起安全问题的药物的使用减少，但总体药物利用率可能没有受到影响。尽管对临床结果的影响不确定，但定量研究表明存在意外的健康后果。定性研究一致表明提供者的行政负担增加。
关于 Part D 对 LTC 影响的经验证据很少。由于可用数据类型的限制，定量研究在方法学严谨性方面普遍存在不足。定性研究报告缺乏清晰度。随着未来研究使用临床医疗保险数据，预计研究质量将得到提高。
尽管 LTC 特定政策仍在不断发展，但似乎处方药物福利可能需要进一步修改，以更有效地满足 LTC 居民独特的药物需求并改善他们的健康结果。可能需要对 Part D 进行调整，使其更能适应 LTC 处方药物提供流程。
