Cerebral Inc., a fast-growing mental health and medication management startup based in San Francisco, recently announced it will stop prescribing most controlled substances to new patients starting this Friday. Existing patients will be transitioned to local providers or off controlled substances by October 15. This change is a direct response to telehealth controlled substance prescribing changes tied to the expiration of the Drug Enforcement Administration’s (DEA) waiver to the Ryan Haight Act. This waiver allowed telehealth companies to prescribe controlled substances remotely during the COVID-19 pandemic, fueling rapid growth in virtual mental health care.
Chief Medical Officer David Mou informed Cerebral’s prescriber team that the company is adjusting its practices to comply with these telehealth controlled substance prescribing changes. To support clinicians, Cerebral will offer mandatory training and resources to ensure patient safety and smooth transitions. This training aims to help providers navigate the evolving regulatory landscape while maintaining the highest standards of care. The transition period is designed to minimize disruption for patients, offering them continuity through local care or alternative treatments.
How Telehealth Controlled Substance Prescribing Changes Affect Care
The Ryan Haight Act originally required an in-person visit before prescribing controlled substances. The DEA’s temporary waiver allowed telehealth providers like Cerebral to prescribe medications remotely, expanding access to medication-assisted treatment (MAT) and other mental health services. As the waiver expires, telehealth controlled substance prescribing changes are forcing companies to adapt to stricter regulations.
This regulatory shift challenges telehealth providers to find new ways to balance accessibility and compliance. For patients living in rural or underserved areas, telehealth has been a lifeline, offering convenient and timely care without the need to travel. The rollback of the waiver complicates this dynamic, potentially limiting access to critical medications for some populations. Cerebral’s decision to halt most controlled substance prescriptions for new patients reflects these challenges.
Nevertheless, Cerebral plans to continue prescribing controlled substances through its virtual MAT program, which specifically supports patients managing both mental health and substance use disorders. This approach allows Cerebral to maintain a focus on integrated care for complex cases, while adapting to regulatory realities.
Increased Scrutiny and Legal Challenges Amid Telehealth Controlled Substance Prescribing Changes
Cerebral’s ADHD medication prescribing, especially for Adderall, has been heavily scrutinized within the context of telehealth controlled substance prescribing changes. The company has ceased all Adderall prescriptions due to concerns about safety and overprescribing.
Pharmacy partners such as Truepill and CVS Health have restricted or stopped filling Cerebral’s controlled substance prescriptions, reflecting industry caution related to these telehealth controlled substance prescribing changes. Legal action has also arisen, with a grand jury subpoena investigating Cerebral’s practices, adding to the regulatory pressure.
Internal whistleblowers have raised safety concerns as well, highlighting the challenges Cerebral faces amid these prescribing changes. These events underscore the importance of oversight in telehealth prescribing practices, particularly when controlled substances are involved. The evolving landscape of regulations and public scrutiny means companies like Cerebral must continuously review and improve their policies to ensure ethical and safe patient care.
Leadership Shifts and Focus on Patient Safety
Responding to regulatory and internal pressures tied to telehealth controlled substance prescribing changes, Cerebral’s leadership has acknowledged past mistakes and recommitted to patient safety. Chief Medical Officer David Mou pointed out that ADHD treatment is a small part of the company’s business, with most patients treated for depression, anxiety, PTSD, and bipolar disorder—conditions less reliant on controlled substances.
CEO Kyle Robertson announced a leadership restructure emphasizing safety and compliance, coinciding with the halt in ADHD controlled substance prescriptions. This move reflects Cerebral’s strategic response to telehealth controlled substance prescribing changes.
By elevating executives with a strong focus on safety to senior roles, Cerebral aims to rebuild trust with patients, providers, and regulators. This leadership overhaul also reflects a broader industry trend toward increased accountability and quality assurance in telehealth services.
What This Means for Patients and the Industry
Patients currently prescribed controlled substances will transition to local care or alternative treatments by mid-October, supported by training for Cerebral’s providers. The telehealth industry is watching closely as telehealth controlled substance prescribing changes return regulations to a stricter standard, requiring providers to balance accessibility with compliance.
Continuing controlled substance prescribing through the virtual MAT program shows one way telehealth providers can adapt while still meeting patients’ complex needs.
The broader impact on the telehealth industry is significant. Providers must now invest more heavily in compliance infrastructure and patient safety protocols. Some smaller startups may struggle to adjust, potentially leading to consolidation or exits from the market. Meanwhile, patients may face increased barriers to access, underscoring the need for innovation in care delivery models.
Conclusion
Cerebral Inc.’s decision to stop most controlled substance prescriptions reflects the significant impact of telehealth controlled substance prescribing changes on virtual mental health care. As regulatory waivers expire, telehealth companies must evolve to ensure patient safety, compliance, and sustainable growth. Cerebral’s experience highlights the challenges and opportunities posed by these important changes.
The company’s efforts to balance regulatory compliance with patient-centered care offer a valuable example for the telehealth industry as it navigates a rapidly shifting landscape. With continued focus on leadership, training, and integrated treatment approaches, telehealth providers can continue expanding access while prioritizing safety and quality.
