Impact of Medicare Part D opioid safety policies on disabled beneficiaries before and during the COVID-19 pandemic

项目摘要/摘要 约占美国人口的3%，非老年残疾人医疗保险受益人(以下简称残疾人 在与处方阿片类药物有关的过量死亡和住院治疗中，约有25%是由“受益人”造成的。 在残疾受益人中，与阿片类药物相关的损害集中在长期服用阿片类药物的20%-25%的人身上。 长期阿片类药物治疗，主要用于慢性疼痛。我们将首先检查最近一项重要政策的效果 干预-Medicare Part D阿片类药物安全编辑-关于研究不足的高危残疾人队列 长期、大剂量阿片类药物治疗的受益者(目标1)。自2019年1月1日起生效 联邦医疗保险D部分计划需要将一套增强的安全编辑纳入其药物使用中 审查系统。最引人注目的是当药剂师每天服用阿片类药物时，提醒药剂师进行护理协调编辑 处方超过90毫克吗啡当量。新的Medicare Part D阿片类药物安全政策是 旨在通过药剂师和处方医生的咨询来识别过度处方，而不直接限制 患者访问权限(预期的受益效果)。它还可能鼓励丁丙诺啡开始用于阿片类药物。 替代大剂量阿片类药物的紊乱治疗(有益的溢出效应)。然而，可能的 将90 MME的门槛误解为“硬停”，再加上行政负担，可能会促使 迅速减少剂量和突然停止(意外的有害影响)。此外，代表人数过多 在残疾受益人中，种族/少数民族患者和农村患者受益的可能性可能较小 来自医疗保险D部分的阿片类药物安全政策，更容易受到意外伤害(目标2)。这个 联邦医疗保险D部分阿片类药物安全政策现在是在新冠肺炎大流行的背景下实施的。至 为了最大限度地减少对医疗保健的潜在干扰，联邦政府对 联邦医疗保险远程保健和阿片类药物法规，这可能会促进联邦医疗保险D部分的益处 阿片类药物安全政策和减轻有害政策影响(目标3)。我们将使用2017-22年度的联邦医疗保险索赔 数据和准实验设计。我们将评估适当的阿片类药物缩减(预期的有益效果)， 不适当的阿片类药物缩减(意外有害影响)、丁丙诺啡启动(有益的溢出效应) 影响)，以及急诊科和住院环境中与阿片类药物相关的不良事件(下游 效果)。我们的目标是：1.检查大流行前第一年实施联邦医疗保险D部分的效果 对长期接受大剂量阿片类药物治疗的残疾受益人实施阿片类药物安全政策； 比较种族/民族和城乡政策效果的差异；3.将目标1和目标2扩大到大流行病 和大流行后时代，以阐明联邦医疗保险D部分阿片类药物安全政策与灵活性的相互作用 在新冠肺炎紧急事件期间和之后提供的。我们的发现将使决策者能够制定 针对残疾人口、种族/民族在临床和文化上有细微差别的政策和做法 少数族裔患者和农村患者，以及不断变化的大流行/大流行后环境。

PROJECT SUMMARY/ABSTRACT Representing ~3% of the U.S. population, non-elderly disabled Medicare beneficiaries (henceforth “disabled beneficiaries”) account for ~25% of overdose deaths and hospitalizations related to prescription opioids. Among disabled beneficiaries, opioid-related harms are concentrated in the 20-25% who are prescribed long- term opioid therapy, primarily for chronic pain. We will first examine effects of a recent, important policy intervention – Medicare Part D opioid safety edits – on an understudied, high-risk cohort of disabled beneficiaries who are prescribed long-term, high-dose opioid therapy (Aim 1). Effective January 1, 2019, Medicare Part D plans are required to incorporate a set of enhanced safety edits into their drug utilization review systems. The most salient is a “care coordination edit” alerting pharmacists when daily doses of opioid prescriptions exceed 90 morphine milligram equivalence. The new Medicare Part D opioid safety policy is intended to identify overprescribing through pharmacist-prescriber consultation without directly restricting patient access (intended beneficial effect). It may also encourage the initiation of buprenorphine for opioid use disorder treatment in lieu of high-dose opioid regimes (beneficial spillover effect). However, the possible misinterpretation of the 90-MME threshold as a “hard stop”, coupled with administrative burdens, may prompt rapid dose reduction and abrupt discontinuation (unintended detrimental effect). Furthermore, overrepresented among disabled beneficiaries, racial/ethnic minority patients and rural patients may be less likely to benefit from the Medicare Part D opioid safety policy and more susceptible to unintended harms (Aim 2). The Medicare Part D opioid safety policy is now playing out against a backdrop of the COVID-19 pandemic. To minimize potential disruptions to health care, the federal government has made temporary changes to the Medicare telehealth and opioid regulations, which may facilitate the beneficial effects of the Medicare Part D opioid safety policy and alleviate the detrimental policy effects (Aim 3). We will use 2017-22 Medicare claims data and a quasi-experimental design. We will assess appropriate opioid tapering (intended beneficial effect), inappropriate opioid tapering (unintended detrimental effect), buprenorphine initiation (beneficial spillover effect), and opioid-related adverse events in emergency department and inpatient settings (downstream effect). We aim to: 1. Examine effects of the first-year, pre-pandemic implementation of the Medicare Part D opioid safety policy on disabled beneficiaries who are prescribed long-term, high-dose opioid therapy; 2. Compare racial/ethnic and rural-urban differences in policy effects; 3. Extend Aims 1 and 2 to the pandemic and post-pandemic eras to elucidate the interaction of the Medicare Part D opioid safety policy with flexibilities provided during the COVID-19 emergency and beyond. Our findings will enable policymakers to develop clinically and culturally nuanced policies and practices tailored to the disabled population, the racial/ethnic minority patients and rural patients, and the evolving pandemic/post-pandemic environment.