What You Should Know:

您应该知道：

– Cerebral, Inc., an online mental healthcare provider, has entered into a non-prosecution agreement (NPA) with the U.S. Attorney’s Office for the Eastern District of New York to pay more than $3.6M to resolve allegations that it engaged in practices that facilitated the unauthorized distribution of controlled substances from 2019 to 2022..

–在线精神保健提供商Cerebral，Inc.已与纽约东区美国检察官办公室签订不起诉协议（NPA），支付360多万美元，以解决2019年至2022年期间其参与促进未经授权分发受控物质的行为的指控。。

– Founded in 2020, Cerebral offers telehealth services aimed at providing mental health treatment, including medication management and therapy for conditions such as depression, anxiety, and ADHD (Attention Deficit Hyperactivity Disorder). The company gained traction quickly, becoming one of the fastest-growing online healthcare platforms in the United States..

–成立于2020年，大脑提供远程保健服务，旨在提供心理健康治疗，包括药物管理和抑郁症、焦虑症和多动症（ADHD）等疾病的治疗。该公司迅速发展壮大，成为美国增长最快的在线医疗保健平台之一。。

The Allegations: Unauthorized Distribution of Controlled Substances

指控：未经授权分发受管制物质

Cerebral primarily operated on a subscription-based model, offering tiered service plans that granted patients access to healthcare providers via video consultations. Some of the plans allowed patients to obtain prescriptions for medications, including controlled substances such as Adderall, a stimulant used to treat ADHD..

。一些计划允许患者获得药物处方，包括用于治疗多动症的兴奋剂Adderall等受控物质。。

In October 2020, the company expanded its services to include the prescription of Schedule II controlled substances (drugs with a high potential for abuse), which set off a chain of events that would ultimately lead to the company’s legal troubles. From 2021 to 2022, Cerebral allegedly engaged in business practices designed to increase prescriptions of stimulant medications such as Adderall to patients, particularly those diagnosed with ADHD.

2020年10月，该公司扩大了其服务范围，包括处方附表二管制物质（极有可能滥用的药物），这引发了一系列事件，最终将导致该公司的法律纠纷。从2021年到2022年，据称大脑从事商业实践，旨在增加患者（尤其是被诊断患有多动症的患者）的兴奋剂药物处方，如阿达拉尔。

However, the company’s internal metrics and goals put pressure on healthcare providers to prescribe medication inappropriately, even when not clinically warranted..

然而，该公司的内部指标和目标给医疗保健提供者施加了压力，要求他们不适当地开药，即使没有临床保证。。

Key elements of the allegations include:

指控的关键因素包括：

Prescribing targets: Cerebral set ambitious internal targets to increase its “Initial Visit Rx Rate”, which tracked the percentage of new patients receiving prescriptions for controlled substances after their first consultation. Between May 2021 and May 2022, the company sought to reach a 95% prescription rate for new patients, despite concerns that this could encourage overprescribing.ADHD-specific prescribing: Cerebral also focused on increasing prescriptions for ADHD stimulants and set a goal to achieve a 100% prescription rate for ADHD patients without considering potential risks, such as misdiagnoses or overmedication.Drug diversion risks: Reports indicated that Cerebral failed to implement effective measures to prevent drug diversion—the practice of diverting controlled substances for non-medical use.

处方目标：大脑制定了雄心勃勃的内部目标，以提高其“初次就诊Rx率”，该目标跟踪首次咨询后接受受控物质处方的新患者的百分比。2021年5月至2022年5月期间，该公司试图为新患者达到95%的处方率，尽管担心这可能会鼓励过度处方。ADHD特异性处方：大脑还专注于增加ADHD兴奋剂的处方，并设定目标，在不考虑潜在风险（如误诊或过度用药）的情况下，为ADHD患者实现100%的处方率。药物转移风险：报告表明，大脑未能采取有效措施防止药物转移将受管制物质转移至非医疗用途的做法。

This was exacerbated by issues like duplicate patient accounts, which allowed individuals to obtain prescriptions from multiple providers within the same company..

重复的患者账户等问题加剧了这种情况，这些问题允许个人从同一家公司的多个提供者那里获得处方。。

The Non-Prosecution Agreement (NPA)

不起诉协议（NPA）

As part of the NPA, Cerebral has agreed to forfeit $3,652,000 to the United States, representing the amount of revenue linked to the increase in ADHD treatment and stimulant prescriptions. The company will also pay a deferred fine of $2,922,000, which will be waived if Cerebral complies with the terms of the NPA over a 30-month period..

作为NPA的一部分，Ceral已同意向美国没收3652000美元，相当于与ADHD治疗和兴奋剂处方增加有关的收入。该公司还将支付2922000美元的延期罚款，如果大脑在30个月内符合NPA的条款，则可以免除该罚款。。

Cerebral has expressed a commitment to remediation and corporate responsibility in response to the legal outcome. The company has acknowledged its past mistakes, implemented significant changes to its operational practices, and pledged to work with authorities to ensure full compliance with the law..

大脑已表示致力于补救和公司责任，以应对法律结果。该公司承认了过去的错误，对其运营实践进行了重大改变，并承诺与当局合作，确保完全遵守法律。。

“Today’s settlement holds Cerebral responsible for their failure to protect patients from the harms caused by the unnecessary or overprescribing of potentially-addictive ADHD medications,” said DEA Administrator Anne Milgram. “Cerebral’s exploitation of telemedicine flexibilities deceived patients who were legitimately seeking medical care, putting them at risk in exchange for profit.

DEA管理员安妮·米尔格拉姆（AnneMilgram）说：“今天的和解要求大脑对他们未能保护患者免受不必要或过度使用可能成瘾的多动症药物造成的伤害负责。”。“大脑对远程医疗灵活性的利用欺骗了合法寻求医疗保健的患者，使他们面临风险以换取利润。

DEA remains committed to telemedicine accessibility that supports the health of all patients while also ensuring that telemedicine companies and practitioners prioritize patient health and safety above all else.”.

DEA仍然致力于支持所有患者健康的远程医疗无障碍性，同时确保远程医疗公司和从业者将患者健康和安全置于首位。”。