DOJ Investigation into Done Global Inc.: Telemedicine Adderall Provider Under Scrutiny
Introduction
Done Global Inc., a prominent telehealth provider specializing in ADHD treatment, is currently under investigation by the Department of Justice (DOJ). The focus of this investigation is on the company's prescribing practices, particularly concerning controlled substances such as Adderall. This scrutiny highlights the broader regulatory and compliance challenges faced by telehealth providers, especially in light of 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 clinicians for the diagnosis and treatment of ADHD through virtual consultations. These consultations can include the prescription of controlled substances like Adderall, Ritalin (methylphenidate), and Vyvanse (lisdexamfetamine).
Services Provided
Patients receive ADHD treatment via 30-minute video evaluations. If deemed necessary, clinicians can prescribe medication following these consultations. This model has become increasingly popular, particularly during the COVID-19 pandemic, which saw a significant rise 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 potential pressures on clinicians to prescribe stimulants without thorough evaluations. These issues have prompted a closer look at Done's compliance with the Controlled Substances Act (CSA).
Legal and Regulatory Framework
The investigation is examining Done's practices under the CSA, which regulates 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, a move that has now led to 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 multiple 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.
Advice to Providers Facing DOJ Target Letters Related to Done
Engage with CCG Healthcare
Providers facing DOJ target letters related to Done or other controlled substance telehealth cases can benefit from the comprehensive services offered by CCG Healthcare. Our team includes former DEA compliance officers and board of medicine inspectors, providing deep expertise in navigating federal investigations.
Conduct Thorough Investigations
CCG Healthcare conducts detailed investigations to gather facts and develop a robust defense. This includes reviewing all relevant documentation, interviewing witnesses, and ensuring that all clinical practices comply with legal standards.
Develop and Implement Corrective Action Plans (CAPs)
If compliance issues are identified, our experts can help develop and implement CAPs. These plans address any deficiencies, ensuring ongoing compliance and minimizing the risk of future penalties.
Ongoing Compliance Monitoring
CCG Healthcare offers ongoing compliance monitoring services to ensure that your practice remains in line with DEA and other regulatory requirements. This proactive approach can prevent future issues and demonstrate a commitment to compliance.
Utilize Expert Guidance
Our experts provide tailored advice and support throughout the investigation process, helping providers understand their legal obligations and how to meet them effectively.
Conclusion
The DOJ's investigation into Done Global Inc. highlights 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. CCG Healthcare's expert consulting services are here to support telehealth providers in maintaining compliance, avoiding penalties, and continuing to deliver high-quality care.
For more detailed information and support, contact us or visit the helpful links below:
DEA Corrective Action Plan Development
Together, we can navigate the complexities of telehealth regulation and achieve compliance success.
