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The opioid industry's use of scientific evidence to advance claims about prescription opioid safety and effectiveness. 阿片类药物行业利用科学证据来宣传处方阿片类药物的安全性和有效性。
Pub Date : 2024-10-24 eCollection Date: 2024-10-01 DOI: 10.1093/haschl/qxae119
Ravi Gupta, Jason Chernesky, Anna Lembke, David Michaels, Cecilia Tomori, Jeremy A Greene, G Caleb Alexander, Adam D Koon

It is widely recognized that pharmaceutical marketing contributed to the ongoing US opioid epidemic, but less is understood about how the opioid industry used scientific evidence to generate product demand, shape opioid regulation, and change clinician behavior. In this qualitative study, we characterize select scientific articles used by industry to support safety and effectiveness claims and use a novel database, the Opioid Industry Documents Archive, to determine notable elements of industry and non-industry documents citing the scientific articles to advance each claim. We found that 15 scientific articles were collectively mentioned in 3666 documents supporting 5 common, inaccurate claims: opioids are effective for treatment of chronic, non-cancer pain; opioids are "rarely" addictive; "pseudo-addiction" is due to inadequate pain management; no opioid dose is too high; and screening tools can identify those at risk of developing addiction. The articles contributed to the eventual normalization of these claims by symbolically associating the claims with scientific evidence, building credibility, expanding and diversifying audiences and the parties asserting the claims, and obfuscating conflicts of interest. These findings have implications for regulators of industry products and corporate activity and can inform efforts to prevent similar public health crises.

人们普遍认为,药品营销是美国阿片类药物持续流行的原因之一,但人们对阿片类药物行业如何利用科学证据产生产品需求、制定阿片类药物法规以及改变临床医生行为的了解较少。在这项定性研究中,我们对阿片行业用于支持安全性和有效性声明的部分科学文章进行了描述,并使用一个新颖的数据库--阿片行业文件档案--来确定引用科学文章来推动每项声明的行业和非行业文件中的显著要素。我们发现,在 3666 份文件中总共提到了 15 篇科学文章,这些文章支持了 5 种常见的、不准确的说法:阿片类药物对治疗慢性非癌症疼痛有效;阿片类药物 "很少 "成瘾;"假性成瘾 "是由于疼痛管理不当造成的;阿片类药物剂量不会过高;筛查工具可以识别有成瘾风险的人群。这些文章将这些说法与科学证据象征性地联系在一起,建立了可信度,扩大了受众和主张这些说法的各方的范围并使其多样化,同时还掩盖了利益冲突,从而促使这些说法最终正常化。这些发现对行业产品和企业活动的监管者具有启示意义,并可为预防类似的公共卫生危机提供参考。
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引用次数: 0
Trends in workplace violence for health care occupations and facilities over the last 10 years. 过去10年保健职业和设施的工作场所暴力趋势。
Pub Date : 2024-10-23 eCollection Date: 2024-12-01 DOI: 10.1093/haschl/qxae134
Brianna Lombardi, Todd Jensen, Evan Galloway, Erin Fraher

Issues of workplace violence (WPV) in health care have garnered increasing attention due to the impact on the health care worker's well-being and retention. Yet, our understanding of whether and how WPV rates vary between health care facilities and occupations is limited, particularly information on growth over time. This information is needed to develop and target policies and interventions toward health care workers and settings most at risk. We examined trends in WPV among health care occupations and facilities over the past decade (2011-2021/2022), utilizing data from the Bureau of Labor Statistics' Survey of Occupational Injuries and Illness. Findings reveal a 30% increase in WPV across all health care facility types between 2011 and 2021/2022; however, there was no difference in the average rate of WPV for health care occupations over the same time period. The increase in WPV for health care facilities began long before the pandemic, suggesting larger systemic issues are likely driving WPV. Existing state and organizational efforts aim to mitigate WPV, yet targeted interventions are crucial. Understanding variations across occupations and facilities will inform tailored strategies to safeguard health care workers.

卫生保健领域的工作场所暴力问题由于对卫生保健工作者的福利和留任的影响而受到越来越多的关注。然而,我们对WPV率在医疗机构和职业之间是否以及如何变化的理解是有限的,特别是关于随时间增长的信息。需要这些信息来制定针对卫生保健工作者和风险最大的环境的政策和干预措施。我们利用劳工统计局职业伤害和疾病调查的数据,研究了过去十年(2011-2021/2022)卫生保健职业和设施中WPV的趋势。调查结果显示,2011年至2021/2022年期间,所有卫生保健机构类型的WPV增加了30%;然而,在同一时期,卫生保健职业的WPV平均率没有差异。卫生保健机构的脊髓灰质炎病例增加早在大流行之前就开始了,这表明可能是更大的系统性问题推动了脊髓灰质炎病例。现有的国家和组织努力旨在减轻野生脊髓灰质炎,但有针对性的干预措施至关重要。了解不同职业和设施之间的差异将为保护卫生保健工作者提供量身定制的策略。
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引用次数: 0
Medigap-guaranteed issue associated with Medicare Advantage disenrollment for beneficiaries administered a part B drug. 与 B 部分药物受益人退出 Medicare Advantage 相关的 Medigap 保证问题。
Pub Date : 2024-10-23 eCollection Date: 2024-11-01 DOI: 10.1093/haschl/qxae136
Angela Liu, David Pittman, Gerard Anderson, Jianhui Xu

While many Medicare beneficiaries are enrolling in Medicare Advantage (MA), some beneficiaries may want to return to traditional Medicare and purchase Medigap, especially beneficiaries who have greater medical needs. Beyond minimal federal regulations, states impose additional regulations that impact Medigap affordability. Beneficiaries in some states have greater difficulty obtaining Medigap coverage because the states where they live allow Medigap insurers to experience rate the beneficiary, which can make Medigap insurance prohibitively expensive. We examined beneficiaries who received physician-administered drugs, which can be expensive and subject to high cost sharing, to see if disenrollment from MA for these beneficiaries was greater in states with Medigap consumer protection policy levels. In 2020, we find a 1.0% average baseline average probability of MA disenrollment. For beneficiaries who received a physician-administered drug in our sample, the probability of MA disenrollment is 3.7 (95% CI, 2.6-4.8; P < .001) percentage points higher in Medigap-guaranteed issue states compared with states with no protections. We find a greater association between MA disenrollment and Medigap protection policies with higher cost drugs. These findings suggest that beneficiaries who receive a high-volume and high-spending physician-administered drug are more likely to disenroll from MA back to traditional Medicare when Medigap is more affordable.

虽然许多联邦医疗保险受益人都加入了联邦医疗保险优势计划(MA),但有些受益人可能希望回到传统的联邦医疗保险并购买 Medigap,尤其是有更多医疗需求的受益人。除了最低限度的联邦法规外,各州还规定了影响 Medigap 可负担性的额外法规。有些州的受益人更难获得 Medigap 保险,因为他们居住的州允许 Medigap 保险公司向受益人收取经验费率,这可能会使 Medigap 保险费用过高。我们对接受医生管理药物的受益人进行了调查,这些药物可能价格昂贵,分担的费用也很高,以了解在 Medigap 消费者保护政策水平较高的州,这些受益人退出 MA 的情况是否更多。2020 年,我们发现医疗保险退出的平均基线概率为 1.0%。对于我们的样本中接受医生管理药物的受益人而言,与没有任何保护措施的州相比,在有 Medigap 保证发行的州中,医疗保险退保的概率要高出 3.7 个百分点(95% CI,2.6-4.8;P < .001)。我们发现,医疗保险退保与 Medigap 保障政策中药物费用较高之间存在较大关联。这些研究结果表明,当 Medigap 更实惠时,接受高用量和高支出医生管理药物的受益人更有可能从医疗保险退保回到传统的医疗保险。
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引用次数: 0
Increased spending on low-value care during the COVID-19 pandemic in Virginia. 弗吉尼亚州 COVID-19 大流行期间低价值护理支出的增加。
Pub Date : 2024-10-23 eCollection Date: 2024-11-01 DOI: 10.1093/haschl/qxae133
Michelle S Rockwell, Sitaram Vangala, Jillian Rider, Beth Bortz, Kyle Russell, Marcos Dachary, Lauryn Walker, A Mark Fendrick, John N Mafi

Characterizing the value and equity of care delivered during the COVID-19 pandemic is crucial to uncovering health system vulnerabilities and informing postpandemic recovery. We used insurance claims to evaluate low-value (no clinical benefit, potentially harmful) and clinically indicated utilization of a subset of 11 ambulatory services within a cohort of ∼2 million Virginia adults during the first 2 years of the pandemic (March 1, 2020-December 31, 2021). In 2020, low-value and clinically indicated utilization decreased similarly, while in 2021, low-value and clinically indicated utilization were 7% higher and 4% lower, respectively, than prepandemic rates. Extrapolated to Virginia's population of insured adults, ∼$1.3 billion in spending was associated with low-value utilization of the 11 services during the study period, with 2021 spending rates 6% higher than prepandemic rates. During March 1, 2020-December 31, 2021, low-value and clinically indicated utilization were 15% and 16% lower, respectively, than pre-pandemic rates among patients with the greatest socioeconomic deprivation but similar to prepandemic rates among patients with the least socioeconomic deprivation. These results highlight widening healthcare disparities and underscore the need for policy-level efforts to address the complex drivers of low-value care and equitably redistribute expenditures to services that enhance health.

描述 COVID-19 大流行期间提供的医疗服务的价值和公平性对于发现医疗系统的薄弱环节和为大流行后的恢复提供信息至关重要。我们利用保险索赔来评估大流行头两年(2020 年 3 月 1 日至 2021 年 12 月 31 日)期间弗吉尼亚州 200 多万成年人对 11 项门诊服务子集的低价值(无临床益处,可能有害)和临床指示性使用情况。2020年,低价值和临床指示性使用率同样下降,而2021年,低价值和临床指示性使用率分别比大流行前的比率高7%和低4%。将弗吉尼亚州的投保成年人口推断,在研究期间,与11种服务的低价值使用相关的支出为13亿美元,2021年的支出率比流行前的比率高出6%。在 2020 年 3 月 1 日至 2021 年 12 月 31 日期间,在社会经济贫困程度最高的患者中,低价值使用率和临床指示使用率分别比流行前低 15%和 16%,但在社会经济贫困程度最低的患者中,低价值使用率和临床指示使用率与流行前相似。这些结果凸显了医疗保健差距的扩大,并强调需要在政策层面努力解决低价值医疗的复杂驱动因素,并将支出公平地重新分配给增进健康的服务。
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引用次数: 0
Learning from employer experiences with paid leave policy expansions during the COVID-19 pandemic. 从 COVID-19 大流行期间扩大带薪休假政策的雇主经验中学习。
Pub Date : 2024-10-21 eCollection Date: 2024-10-01 DOI: 10.1093/haschl/qxae122
William H Dow, Julia M Goodman, Paloma Lin, Paige Park

The United States does not have a federal policy offering employees paid leave. We study employer attitudes toward the Families First Coronavirus Response Act (FFCRA) federal emergency paid leave policies temporarily adopted during the COVID-19 pandemic to draw lessons for proposed permanent federal paid leave policies. We analyzed a 2021 survey of 300 San Francisco Bay Area employers to examine employers' experiences with paid sick leave (PSL) and paid family leave (PFL) policies during the COVID-19 pandemic, along with their attitudes regarding FFCRA paid leave. Most firms reported that it was not difficult to comply with or seek reimbursement for FFCRA leave. Nevertheless, most smaller firms did report difficulty in understanding policy details, and many reported being unaware of FFCRA paid leave availability. FFCRA paid leave was broadly popular among firms aware of it: 64% supported (9% opposed) the PSL provisions, and 52% supported (12% opposed) PFL. However, support for permanent extension dropped to just over 40%, despite this Bay Area sample having long familiarity with California's state paid leave policies. We conclude that federal pandemic paid leave offers a potential model that could be refined for future paid leave policies, but support is mixed.

美国没有为雇员提供带薪休假的联邦政策。我们研究了雇主对在 COVID-19 大流行期间临时采用的《家庭第一冠状病毒应对法案》(FFCRA)联邦紧急带薪休假政策的态度,以便为拟议的永久性联邦带薪休假政策提供借鉴。我们分析了 2021 年对旧金山湾区 300 名雇主进行的调查,以研究雇主在 COVID-19 大流行期间使用带薪病假 (PSL) 和带薪家事假 (PFL) 政策的经验,以及他们对 FFCRA 带薪休假的态度。大多数公司表示,遵守或申请报销 FFCRA 假期并不困难。然而,大多数小公司确实表示在了解政策细节方面存在困难,许多公司表示不知道 FFCRA 规定了带薪休假。在了解 FFCRA 带薪休假的公司中,FFCRA 带薪休假广受欢迎:64% 的公司支持(9% 反对)PSL 条款,52% 的公司支持(12% 反对)PFL 条款。然而,尽管湾区的样本对加州的带薪休假政策非常熟悉,但对永久延长带薪休假的支持率却下降到了 40% 多一点。我们的结论是,联邦大流行病带薪休假提供了一个潜在的模式,可用于完善未来的带薪休假政策,但支持率参差不齐。
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引用次数: 0
No Surprises Act independent dispute resolution outcomes for emergency services. 无意外法》为紧急服务提供独立的争议解决结果。
Pub Date : 2024-10-17 eCollection Date: 2024-11-01 DOI: 10.1093/haschl/qxae132
Erin L Duffy, Christopher Garmon, Loren Adler, Adam Biener, Erin Trish

The No Surprises Act banned surprise billing and established a final-offer arbitration system, independent dispute resolution (IDR), to resolve disagreements between health plans and providers. One factor that arbiters must consider in the IDR process is the qualifying payment amount (QPA), the median contracted rate for the same or similar service in the same market as computed by health plans. We analyzed public IDR data from 2023 for the most common disputed professional service: evaluation and management of a moderate to severe emergency medicine visit. Providers won 86% of cases, with mean decisions 2.7 times the QPA. Private equity-backed providers won more often and higher monetary awards than other providers. The mean QPA was 2.4 times Medicare payments. Disputes were dominated by a small group of health plans and providers, so payments may not reflect the overall market for emergency services.

无意外法案》禁止突击收费,并建立了最终报价仲裁制度--独立争议解决 (IDR),以解决医疗计划与医疗服务提供者之间的分歧。仲裁员在 IDR 程序中必须考虑的一个因素是合格支付金额 (QPA),即医疗计划计算的同一市场中相同或类似服务的合同费率中值。我们分析了 2023 年最常见争议专业服务的公开 IDR 数据:中度至重度急诊就诊的评估和管理。医疗机构在 86% 的案件中胜诉,平均裁决是 QPA 的 2.7 倍。与其他医疗服务提供者相比,私募股权支持的医疗服务提供者胜诉率更高,获得的赔偿金额也更高。平均 QPA 是医疗保险付款的 2.4 倍。纠纷主要由一小部分医疗计划和医疗服务提供者引起,因此支付金额可能无法反映急诊服务的整体市场情况。
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引用次数: 0
Performance of the Washington Group questions in measuring blindness and deafness. 华盛顿小组问题在测量失明和失聪方面的表现。
Pub Date : 2024-10-15 eCollection Date: 2024-11-01 DOI: 10.1093/haschl/qxae131
Scott D Landes, Bonnielin K Swenor, Jean P Hall

The Washington Group Short Set (WGSS) questions are intended to measure the severity of disability and disability status in US federal surveys. We used data from the 2010-2018 National Health Interview Survey to examine the performance of the WGSS visual disability and hearing disability questions in capturing blindness and deafness. We found that the WGSS questions failed to capture 35.7% of blind adults and 43.7% of deaf respondents as having a severe disability, or, per their recommended cut point, as being disabled. Coupled with evidence demonstrating the poor performance of the WGSS questions in estimating the size of the overall disability population, we contend that results from this study necessitate a halt in the use of the WGSS questions to measure disability in US federal surveys.

在美国联邦调查中,华盛顿组简易问题集(WGSS)问题旨在测量残疾的严重程度和残疾状况。我们利用 2010-2018 年全国健康访谈调查的数据,研究了 WGSS 视力残疾和听力残疾问题在捕捉失明和失聪方面的表现。我们发现,WGSS 的问题未能将 35.7% 的成年盲人和 43.7% 的聋人受访者视为严重残疾,或按照其建议的切点视为残疾。再加上有证据表明 WGSS 问题在估算整体残疾人口数量方面表现不佳,我们认为本研究的结果表明有必要停止在美国联邦调查中使用 WGSS 问题来测量残疾情况。
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引用次数: 0
Correction to: The state of health information organizations and plans to participate in the federal exchange framework. 更正为医疗信息组织和计划参与联邦交换框架的情况。
Pub Date : 2024-10-15 eCollection Date: 2024-10-01 DOI: 10.1093/haschl/qxae130

[This corrects the article DOI: 10.1093/haschl/qxae098.].

[此处更正了文章 DOI:10.1093/haschl/qxae098]。
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引用次数: 0
Correction to: An increasing number of states filled Conrad 30 waivers for recruiting international medical graduates. 更正:越来越多的州为招聘国际医学毕业生填写了康拉德 30 号豁免书。
Pub Date : 2024-10-14 eCollection Date: 2024-10-01 DOI: 10.1093/haschl/qxae121

[This corrects the article DOI: 10.1093/haschl/qxae103.].

[此处更正了文章 DOI:10.1093/haschl/qxae103]。
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引用次数: 0
Evidence to inform biopharmaceutical policy: call for research on the impact of public policies on investment in drug development. 为生物制药政策提供信息的证据:呼吁研究公共政策对药物开发投资的影响。
Pub Date : 2024-10-10 eCollection Date: 2024-12-01 DOI: 10.1093/haschl/qxae129
Sandra Barbosu, Kirsten Axelsen, Stephen Ezell

This paper highlights the pressing need for updated, robust evidence to inform biopharmaceutical policy, particularly in light of recent initiatives such as the Inflation Reduction Act. Current estimates that inform such policies, including those from the Congressional Budget Office, rely on outdated data and models that fail to fully capture the complexities of modern investment decisions or the broader impact of policies on drug development in areas like oncology, rare diseases, and vaccines. Understanding how expectations of financial returns influence investment in all stages of drug development is critical for evaluating these policies' long-term effects on innovation. This piece reviews the current evidence on the relationship between financial returns and research and development investment and considers how this evidence is being used to shape biopharmaceutical policy. It also highlights gaps in data and methodology, emphasizing the need for better models that reflect real-world trade-offs, investment risks, and therapeutic area-specific impacts. Finally, this paper calls for improved access to federal and private data to better inform evidence-based policymaking and to study policy impact on investments in the next generation of medicines, particularly in emerging fields like gene and cell therapies, where the implications of policy decisions are not yet fully understood.

本文强调迫切需要最新的、有力的证据来为生物制药政策提供信息,特别是考虑到最近的举措,如《通货膨胀减少法》。包括国会预算办公室(Congressional Budget Office)在内,目前为此类政策提供信息的估计依赖于过时的数据和模型,无法充分反映现代投资决策的复杂性,也无法充分反映政策对肿瘤、罕见疾病和疫苗等领域药物开发的更广泛影响。了解财务回报预期如何影响药物开发各个阶段的投资,对于评估这些政策对创新的长期影响至关重要。这篇文章回顾了目前关于财务回报与研发投资之间关系的证据,并考虑了如何利用这些证据来制定生物制药政策。它还强调了数据和方法上的差距,强调需要更好的模型来反映现实世界的权衡、投资风险和治疗领域的特定影响。最后,本文呼吁改善对联邦和私人数据的获取,以便更好地为基于证据的政策制定提供信息,并研究政策对下一代药物投资的影响,特别是在基因和细胞疗法等新兴领域,在这些领域,政策决策的影响尚未得到充分理解。
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引用次数: 0
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