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

项目总结/摘要 非老年残疾人医疗保险受益人（以下简称“残疾人”）约占美国人口的3%， 受益人”）约占处方阿片类药物过量死亡和住院的25%。 在残疾受益人中，阿片类药物相关的危害集中在20-25%的长期处方中， 长期阿片类药物治疗，主要用于慢性疼痛。我们将首先考察最近一项重要政策的影响 干预-医疗保险D部分阿片类药物安全编辑-对一个未充分研究的高风险残疾人队列 接受长期、高剂量阿片类药物治疗的受益人（目标1）。自2019年1月1日起， 医疗保险D部分计划需要将一系列增强的安全编辑纳入其药物利用中 审查制度。最突出的是一个“护理协调编辑”，提醒药剂师，当每日剂量的阿片类药物 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-处方者咨询来识别过度处方，而不直接限制 患者访问（预期有益效果）。它也可能鼓励丁丙诺啡用于阿片类药物的使用 用失调治疗代替高剂量阿片类药物方案（有益的溢出效应）。然而， 将90-MME阈值误解为“硬停止”，再加上管理负担， 快速减量和突然停药（非预期的有害作用）。此外， 在残疾受益人中，种族/少数民族患者和农村患者可能不太可能受益 从医疗保险D部分阿片类药物安全政策，更容易受到意外伤害（目标2）。的 在COVID-19大流行的背景下，医疗保险D部分阿片类药物安全政策正在发挥作用。到 为了最大限度地减少对医疗保健的潜在干扰，联邦政府已经对医疗保健进行了临时修改。 医疗保险远程医疗和阿片类药物法规，这可能有助于医疗保险D部分的有益效果 阿片类药物安全政策和减轻有害的政策影响（目标3）。我们将使用2017-22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减量（预期的有益效果）， 阿片类药物减量不当（非预期有害作用），丁丙诺啡开始（有益溢出 影响），以及急诊科和住院环境中的阿片类药物相关不良事件（下游 效果）。我们的目标是：1.检查大流行前实施Medicare Part D第一年的效果 对长期、高剂量阿片类药物治疗的残疾受益人的阿片类药物安全政策; 2. 比较种族/民族和城乡政策效果的差异; 3.将目标1和2扩大到大流行病 和大流行后时期，以阐明医疗保险D部分阿片类药物安全政策与灵活性的相互作用 在COVID-19紧急情况期间及之后提供。我们的研究结果将使决策者能够制定 针对残疾人口、种族/族裔群体和残疾人群体制定的在临床和文化上有细微差别的政策和做法， 少数民族患者和农村患者，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.