Introduction
Done Global Inc., is a prominent telehealth provider specializing in ADHD treatment. The company is currently under investigation by the Department of Justice (DOJ), where the main focus of this investigation remains on the company’s prescribing practices, particularly concerning controlled substances such as Adderall.
While Done Global Inc. is a prime example of the scrutiny surrounding prescribing practices and the legitimate medical need of telehealth patients, telehealth platform modalities in general highlight 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.
At Safe Harbor Group, our experts pride themselves on their telehealth regulatory knowledge, even as compliance standards change rapidly within the industry. Additionally, SHG’s unmatched litigation support acts as a beacon for healthcare providers through a confusing landscape of reactive government persecution.
Background on Done Global Inc.
Company Overview
Done Global Inc. offers telehealth services which connect patients with clinicians for the diagnosis and treatment of ADHD through virtual consultations. Before Done Global Inc. was under investigation by the DOJ, consultations included the prescription of controlled substances like Adderall, Ritalin (methylphenidate), and Vyvanse (lisdexamfetamine).
As of 2024, perhaps in response to the investigation, the company states the following on its website: “You cannot get ADHD medications directly through a telehealth platform. The role of the telehealth platform is to act as a gateway to the right medical practitioners that can help perform an official diagnosis and allow for remote interactions that would otherwise not be possible or slow the entire process.” Also of note, “Done. connects patients with providers in their location that can help ADHD patients identify the personalized treatment they need.”
Services Provided
Patients received ADHD treatment via 30-minute video evaluations. If deemed necessary, clinicians could prescribe medication following these consultations. This model of telemedicine has become increasingly popular since the Covid-19 pandemic, which saw a significant increase in telehealth and telemedicine offerings as well as subscription models of treatment. Done Global Inc. successfully capitalized on the rise of these types of services and is alleged by the DOJ to have generated over $100 million in the prescribing of over 40 million stimulant pills.
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 current investigation will examine 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.
he exceptions to the Ryan Haight Online Pharmacy Consumer Protection Act include:
Telemedicine during a public health emergency: The law allows for prescriptions via telemedicine without an in-person evaluation if the Secretary of Health and Human Services declares a public health emergency. This provision was used during the COVID-19 pandemic, allowing broader access to medications like Adderall via telehealth services.
The exceptions to the Ryan Haight Online Pharmacy Consumer Protection Act include:
● Telemedicine during a public health emergency: The law allows for prescriptions via telemedicine without an in-person evaluation if the Secretary of Health and Human Services declares a public health emergency. This provision was used during the COVID-19 pandemic, allowing broader access to medications like Adderall via telehealth services.
● Indian Health Service practitioners: Practitioners working within the Indian Health Service (IHS) or tribal organizations are exempt from the in-person requirement under certain circumstances.
● Qualified practitioners: Some qualified practitioners, such as those who provide care in a hospital or clinic that has been registered with the Drug Enforcement Administration (DEA), may prescribe controlled substances without an in-person evaluation if they follow specific telemedicine protocols.
● Special registration: The Act allows for special telemedicine registrations that would enable providers to prescribe controlled substances remotely without the in-person visit. Although this provision was included in the original legislation, the regulations regarding this special registration process have been delayed and were only revisited more extensively during the COVID-19 pandemic.
● Prison or correctional settings: If a patient is being treated by a healthcare provider who is practicing within a correctional facility, the in-person requirement may be waived, allowing telemedicine for controlled substance prescriptions.
● Department of Veterans Affairs (VA) medical services: VA healthcare providers can prescribe controlled substances via telemedicine without an in-person exam under certain conditions related to their work within the VA system.
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. The five federal schedules are as follows:
Schedule I:
● Description: These drugs have a high potential for abuse and no accepted medical use in the U.S. They are not considered safe for medical use, even under supervision.
● Examples: Heroin, LSD, marijuana (cannabis), ecstasy (MDMA), peyote.
Schedule II:
● Description: Drugs in this category have a high potential for abuse, which can lead to severe psychological or physical dependence, but they have accepted medical uses with strict restrictions.
● Examples: Cocaine, methamphetamine, methadone, oxycodone (OxyContin), fentanyl, Adderall, Ritalin.
Schedule III:
● Description: These substances have a lower potential for abuse compared to Schedule I and II drugs and have accepted medical uses. Abuse may lead to moderate or low physical dependence or high psychological dependence.
● Examples: Anabolic steroids, testosterone, ketamine, codeine (when combined with other substances like acetaminophen).
Schedule IV:
● Description: These drugs have a low potential for abuse relative to Schedule III substances and have accepted medical uses. Abuse may lead to limited physical or psychological dependence.
● Examples: Xanax (alprazolam), Valium (diazepam), Ativan (lorazepam), Ambien (zolpidem), Tramadol.
Schedule V:
● Description: These substances have the lowest potential for abuse relative to other schedules and have accepted medical uses. They generally consist of preparations containing limited quantities of certain narcotics.
● Examples: Cough preparations with less than 200 milligrams of codeine per 100 milliliters (e.g., Robitussin AC), Lomotil, Motofen, Lyrica.
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 created both opportunities and challenges within the industry, leading to a domino effect of indictments and investigations across multiple platforms.
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. Luckily for healthcare providers and platforms, Safe Harbor Group offers compliance expertise and litigation support services to create clearer pathways to regulatory compliance, no matter the allegations.
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. Indictments occur when healthcare providers and platforms are caught in this reactive whiplash without a compliance plan, which Safe Harbor Group experts can quickly customize no matter the type of practice or its size
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. Without legal support or advice, many telehealth providers flounder under the pressure to perform to ever-changing standards while still offering the services they’ve promised to patients across the country.
Advice to Providers Facing DOJ Target Letters Related to Done
Engage with SHG Healthcare
Providers facing DOJ target letters related to Done or other controlled substance telehealth cases can benefit from the comprehensive services offered by Safe Harbor Group. Our team includes former DEA compliance officers and board of medicine inspectors, providing deep expertise in navigating federal investigations.
Conduct Thorough Investigations
SHG 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
Safe Harbor Group 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. Remaining proactive is critical in staying vigilant against reactive government investigations.
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. Safe Harbor Group’s expert consulting services are here to support telehealth providers in maintaining compliance, avoiding penalties, and continuing to deliver high-quality care.
