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On September 16, the Wall Street Journal reported the DEA’s investigation of Done Global Inc. for its telehealth prescription methods. Done Global is a digital therapeutics company specializing in the remote treatment of Attention Deficit and Hyperactivity Disorder (ADHD). In recent months, the US Drug Enforcement Agency (DEA) has been investigating the telehealth prescription practices of digital therapeutics companies specializing in behavioral care. The Wall Street Journal reported the DEA’s investigation of Done Global Inc for its telehealth prescription practices.
Based on membership, the consumer-facing Done platform asks consumers to complete a 1-minute assessment to schedule a 30-minute appointment on the same day or as soon as the next day with one of their licensed ADHD clinicians. The platform offers “online visits, worry-free refills, 24/7 care with clinicians and care team.”
The Done website’s mission statement explains:
Our approach is simple. After using the Done platform to take a medically approved assessment test to determine if and where a patient falls on the ADHD spectrum, they are connected directly with a medical practitioner to schedule an appointment and privately discuss their wellness. Once the course of treatment is determined with a clinician, a patient has the option to join Done. as a valued member of our services and access a broad network of clinicians.
The website also explains that Done does not offer psychotherapy, but rather medication management:
We do not currently offer therapy or cognitive behavioral therapy; our current focus is on personalized medication management. However, there is a lot of value …
Telehealth Stimulant Prescriptions in the Spotlight
Telehealth prescriptions for stimulants such as Adderall have been in the spotlight in recent months. In May this year, the US Justice Department issued Cerebral Inc with a grand jury subpoena for possibly violating the Controlled Substances Act. Cerebral Inc is Done’s prime competitor. Both organizations are active on social media, often overstating the benefits of ADHD medications.
The Controlled Substances Act categorizes substances based on their medical use, the potential for abuse, and the chances of dependence. Adderall is potentially addictive, and its distribution is restricted. Cerebral stopped issuing Adderall telehealth prescriptions for new patients following the subpoena. The company has stated that management will cooperate with investigators.
Done Global Clinicians Complain of Undue Pressure for ADHD Diagnosis
In March, the Wall Street Journal stated that Done Global clinicians reported feeling pressured into issuing telehealth prescriptions.
- Clinician accusations of pressure to diagnose ADHD and issue telehealth prescription refills are backed up by a 2021 internal report written by Done Global’s former Chief Medical Officer.
- Earlier this year, a Los Angeles man relapsed into drug abuse after a clinician issued a telehealth prescription for Adderall on the Done platform. The man subsequently died of a drug overdose.
- In May, CVS Health and Walmart stopped filling telehealth prescription refills issued by clinicians using the Done Global and Cerebral platforms due to concerns with telehealth prescription practices.
Currently, In-person Examinations Are Not a Requirement for Telehealth Prescription of Stimulants
Before the pandemic, an in-person examination was required before the clinician could issue telehealth prescriptions. This requirement was dropped in January 2020 and will come into force again when the Public Health Emergency ends. This concerns some clinicians as telehealth prescription refills have made it easier for doctors to treat opioid-use disorders.
Clinician Advisory: Liabilities Are Incurred When Working for Online Employers
Done Global management reportedly denies applying pressure for telehealth prescription refills, saying they only provide the platform for consultations. The company does not employ or contract clinicians.
The structure of many highly successful digital healthcare companies allows them to collect fees for marketing and the use of their platforms. The companies typically disclaim associated liability for clinical decisions made by providers. While it is impossible to know the facts of the Done Global case described above or why the DEA is investigating Done, whether a digital healthcare platform can disclaim liability for providers is likely to be tested for years.
Clinicians working with online employers are encouraged to get educated about these issues to protect themselves against undue liability. Telehealth.org feels so strongly about this issue it has organized a 1.5-hour CME and CE program with leaders of two prominent national associations to provide the facts. The podcast/webinar program is titled: Accepting Telehealth Jobs: 5 Big Legal & Ethical Mistakes to Avoid.