DOJ Probe into Done Global Inc.: Telemedicine Adderall Provider Under Investigation

Introduction

Done Global Inc., a notable telehealth provider specializing in ADHD treatment, is currently under investigation by the Department of Justice (DOJ). This investigation focuses on the company's prescribing practices, particularly concerning controlled substances such as Adderall. This scrutiny highlights the broader regulatory and compliance issues faced by telehealth providers, especially given the evolving DEA regulations and the Ryan Haight Online Pharmacy Consumer Protection Act.

Background on Done Global Inc.

Company Overview

Done Global Inc. offers telehealth services that connect patients with healthcare providers for the diagnosis and treatment of ADHD through virtual appointments. These consultations can result in the prescription of controlled substances like Adderall, Ritalin (methylphenidate), and Vyvanse (lisdexamfetamine).

Services Offered

Patients receive ADHD treatment through 30-minute video evaluations. If deemed necessary, clinicians may prescribe medication following these consultations. This model gained popularity during the COVID-19 pandemic, which saw a significant uptick in telehealth services.

Federal Scrutiny and Investigation

DEA Investigation

The DEA is investigating Done Global Inc. for potentially improper prescribing practices. Concerns have been raised about the adequacy of the virtual consultations and possible pressures on clinicians to prescribe stimulants without comprehensive evaluations. These concerns have prompted a closer examination of Done's compliance with the Controlled Substances Act (CSA).

Legal and Regulatory Framework

The investigation is looking into Done's practices under the CSA, which oversees the prescription of potentially addictive medications like Adderall. The Ryan Haight Online Pharmacy Consumer Protection Act, enacted in 2008, requires an in-person medical evaluation before prescribing controlled substances via telemedicine, with certain exceptions. During the pandemic, the DEA temporarily relaxed these requirements to improve access to care, leading to increased regulatory scrutiny.

Regulatory and Legal Context

Temporary Telemedicine Flexibilities

In response to the COVID-19 pandemic, the DEA issued temporary waivers allowing telehealth providers to prescribe controlled substances without an in-person evaluation. These flexibilities, extended several times, enabled Done and other telehealth providers to prescribe ADHD stimulants following virtual consultations.

Proposed Permanent Rules

The DEA has proposed new rules to create permanent pathways for telemedicine prescribing of controlled substances. These rules include specific conditions and safeguards to ensure proper use and are still under consideration following extensive public feedback.

The Controlled Substances Act (CSA) and Legitimate Prescriptions

Overview

The CSA establishes a regulatory framework for the manufacture, distribution, and dispensing of controlled substances. It categorizes drugs into five schedules based on their potential for abuse, medical use, and safety under medical supervision.

Legitimate Medical Purpose

Under the CSA, a prescription for a controlled substance must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. This includes ensuring a thorough diagnosis and evaluation of the patient's medical condition, the necessity of the prescribed medication, and adherence to professional standards.

Company Response and Impact

Done's Position

Done Global Inc. denies receiving any formal notifications from federal agencies regarding an investigation. The company asserts its compliance with all applicable laws and regulations, maintaining that its clinicians make independent clinical decisions.

Operational Challenges

Major pharmacies like CVS Health and Walmart have stopped filling prescriptions from Done, leading to delays and complications for patients needing ADHD medications such as Adderall, Ritalin, and Vyvanse. This has significant implications for patient care and access to necessary treatments.

Broader Implications

Industry Trends

The investigation into Done underscores the regulatory complexities facing telehealth providers, particularly concerning controlled substances. The temporary relaxation of in-person requirements has created both opportunities and challenges within the industry.

Future Directions

Stakeholders are calling for balanced regulations that ensure safe prescribing practices while maintaining access to necessary medications via telehealth. The ongoing public feedback on the DEA's proposed rules will be crucial in shaping the future regulatory landscape.

Critique of the Investigation

Unclear Telemedicine Rules

Current regulations for telemedicine, particularly for prescribing controlled substances, lack clarity and consistency. The DEA's evolving stance and the temporary nature of the COVID-19 waivers have created confusion among providers and patients.

Delayed DEA Action

The DEA's delayed response in addressing the practices of companies like Done has allowed potential issues to persist unaddressed for years. This reactive approach, rather than a proactive one, undermines trust and compliance efforts within the telehealth industry.

Impact on Providers

The uncertainty and regulatory shifts have left many telehealth providers in a precarious position, struggling to navigate the legal landscape while ensuring patient access to necessary treatments.

Understanding Target Letters and Indictments

What is a Target Letter?

A target letter is a formal notification from the DOJ indicating that the recipient is a subject of a federal investigation. According to Ronald W. Chapman's article on federal target letters, receiving a target letter signifies that the DOJ believes the recipient has substantial information relevant to a federal grand jury investigation and could potentially be indicted.

Implications of a Target Letter

Receiving a target letter can have serious legal implications. It is crucial to seek legal counsel immediately upon receipt to understand your rights and obligations. An attorney can help navigate the investigation, negotiate with prosecutors, and potentially mitigate legal risks.

What is an Indictment?

An indictment is a formal charge or accusation of a serious crime. As detailed in Ronald W. Chapman's article on indictments, it means that a grand jury has found sufficient evidence to charge someone with a crime. An indictment initiates a formal criminal proceeding, which can lead to a trial.

Conclusion

The DOJ's investigation into Done Global Inc. underscores the critical importance of regulatory compliance in the telehealth industry. As telemedicine continues to evolve, providers must navigate a complex legal landscape to ensure safe and effective patient care. Understanding the implications of federal investigations, including target letters and indictments, is essential for providers to protect against legal liability.

For more detailed information and support, visit these resources:

• DEA
• American Bar Association
• Ronald W. Chapman Law Articles

By staying informed and proactive, telehealth providers can better navigate regulatory challenges and continue to deliver high-quality care.