Recent investigations and arrests targeting telehealth companies, providing virtual treatment for Attention Deficit Hyperactivity Disorder (ADHD) appear to be part of increased scrutiny in the telehealth sector providing prescriptions for controlled substances. These cases, most notably the indictment of Done Global Inc.’s executives, highlight the heightened scrutiny of digital healthcare practices, and the potential for both innovation and misconduct within this sector. (See https://www.justice.gov/usao-ndca/pr/founderceo-and-clinical-president-digital-health-company-arrested-100m-adderall).
The Case of Done Global: A Case Study in Telehealth Scrutiny
Done Global, a virtual platform offering ADHD treatment, came under scrutiny from the Drug Enforcement Administration (DEA) in 2022, with reports of an ongoing investigation focusing on potential violations of the Controlled Substances Act and concerns about prescription drug diversion. The DEA’s investigation, culminating in the arrests of Done Global’s founder and CEO, alongside its clinical president, raised serious questions about the company’s compliance with regulatory requirements and its ethical practices.
Federal prosecutors allege that Done Global engaged in a pattern of prescribing Adderall without proper patient evaluation, exceeding acceptable standards of care, and potentially facilitating drug diversion.
Expanding Scrutiny Beyond Done Global: A Broader Trend in Telehealth Enforcement
The Done Global case is not an isolated incident. Other telehealth platforms, such as Cerebra Inc., have also faced scrutiny from federal prosecutors, suggesting increased enforcement actions in this sector. (See https://www.wsj.com/articles/dea-investigating-adhd-telehealth-provider-done-11663239601). Moreover, the DEA recently announced it would extend for another year the telehealth flexibilities first enacted during the Covid pandemic. (https://bhbusiness.com/2023/10/06/dea-extends-telehealth-flexibilities-another-year/). These flexibilities have proven popular with providers and consumers because they are convenient and efficient, but they provide greater opportunity for abuse which triggers greater law enforcement scrutiny.
Navigating the Regulatory Minefield: Compliance Challenges for Telehealth Companies
Telehealth presents significant compliance challenges for healthcare providers and their legal counsel. Successfully navigating this regulatory landscape requires a comprehensive understanding of:
- Evolving Regulations: The legal landscape surrounding telehealth is evolving. Staying abreast of new regulations, guidance, and enforcement trends is essential for ensuring compliance.
- Patient Assessment and Diagnosis: Telehealth platforms must adhere to strict standards for patient assessment, ensuring proper diagnoses and appropriate prescribing practices to avoid potential violations of the Controlled Substances Act and related statutes.
- Data Security and Privacy: Protecting patient data and maintaining compliance with privacy regulations, such as HIPAA, is crucial to mitigating legal risk and safeguarding sensitive information.
- Auditing and Transparency: Implementing robust auditing procedures and maintaining transparent record-keeping practices are vital for demonstrating compliance and mitigating regulatory scrutiny.
The Future of Healthcare: A Collaborative Approach for Ethical Innovation
The ongoing scrutiny of telehealth companies highlights the importance for healthcare providers to collaborate with regulatory legal counsel. The adage that an ounce of prevention is worth a pound of cure is especially appropriate in this space. Over the years, we have repeatedly helped clients with major enforcement actions that could have been avoided by engaging good regulatory legal counsel and faithfully following their advice. This approach provides greater protection to telehealth platforms providing services in this uncertain and emerging regulatory environment.
By working together with legal counsel, entrepreneurial providers can navigate evolving landscape and help shape the future of healthcare in a way that balances innovation and regulatory enforcement.
