DEA Intensifies Scrutiny on Online Prescribing of Controlled Substances, Including GLP-1s

Introduction

The Drug Enforcement Administration (DEA) has signaled a significant increase in its enforcement efforts targeting the online prescribing of controlled substances. This heightened scrutiny comes as the healthcare industry continues to adapt to the expansion of telehealth services, a trend significantly accelerated by the COVID-19 Public Health Emergency (PHE). While the DEA's primary focus remains on controlled substances, the broader context of telehealth prescribing, including the rapid rise of medications like GLP-1 agonists (which are not controlled substances), is drawing regulatory attention to the legitimacy and safety of virtual care models.

Background: The Ryan Haight Act and PHE Flexibilities

Prior to the COVID-19 PHE, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 generally required an in-person medical evaluation before a practitioner could prescribe a controlled substance to a patient via the internet. The Act aimed to prevent the unlawful dispensing of controlled substances through rogue online pharmacies. However, during the PHE, the DEA implemented temporary exceptions, allowing practitioners to prescribe controlled substances via telehealth without a prior in-person medical evaluation, provided certain conditions were met. These flexibilities were crucial for ensuring patient access to necessary medications during the pandemic.

As the PHE officially ended on May 11, 2023, the DEA has been in the process of finalizing new rules regarding these telehealth flexibilities. Initially, the DEA proposed a return to stricter in-person requirements for initial controlled substance prescriptions, which drew significant concern from patient advocacy groups and telehealth providers. In response to public comments, the DEA issued a temporary rule extending the full set of telehealth flexibilities for prescribing controlled medications through November 11, 2023, and further extended them until December 31, 2024, for patient-practitioner relationships established on or before November 11, 2023. This extension provides a transition period while the DEA considers permanent regulations. However, this period of transition is also marked by increased vigilance and enforcement against practices deemed non-compliant.

Source: DEA Telehealth Flexibilities

DEA's Enforcement Priorities

The DEA's enforcement actions are rooted in the principle that all prescriptions for controlled substances must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. This principle, often referred to as the 'corresponding responsibility' doctrine, applies not only to the prescribing practitioner but also to the pharmacist who fills the prescription. The DEA is particularly concerned with:

• Diversion: Preventing controlled substances from being diverted from legitimate medical channels to illicit use.
• Patient Safety: Ensuring that patients receive appropriate medical evaluations and care, especially when potentially addictive medications are involved.
• Legitimate Patient-Practitioner Relationship: Verifying that a bona fide relationship exists, based on a comprehensive medical evaluation, rather than merely a patient seeking a prescription online.
• Overprescribing and 'Pill Mills': Combating practices that resemble illicit drug distribution, even if operating under the guise of legitimate medical care.

Recent enforcement trends indicate a focus on telehealth providers who may be perceived as exploiting the PHE flexibilities or operating with insufficient safeguards. This includes investigations into:

• Lack of comprehensive patient evaluations: Prescribing controlled substances without adequate medical history, physical examination (where appropriate), or diagnostic testing.
• High volume prescribing: Practitioners issuing an unusually high number of controlled substance prescriptions, particularly for high-risk medications.
• Questionable marketing practices: Aggressive advertising that promises easy access to controlled substances or targets vulnerable populations.
• Absence of follow-up care: Lack of appropriate monitoring or follow-up for patients receiving controlled substances.

Source: DOJ Press Releases related to Healthcare Fraud

The GLP-1 Connection: Indirect Scrutiny

While GLP-1 receptor agonists (e.g., Ozempic, Wegovy, Mounjaro) are not controlled substances, their burgeoning popularity for weight management has created a parallel regulatory environment that draws DEA's attention to the broader telehealth prescribing landscape. The demand for these medications has led to supply shortages and an increase in online clinics offering them, sometimes compounded or off-label. This context, while not directly under DEA's controlled substance purview, contributes to an environment where regulatory bodies, including state medical boards and the FDA, are scrutinizing online prescribing practices for medical necessity, appropriate patient evaluation, and potential for fraud or misuse.

The DEA's interest in the overall integrity of online prescribing can extend to how GLP-1s are prescribed. If a telehealth platform or clinic prescribing GLP-1s also prescribes controlled substances, or if the prescribing practices for GLP-1s raise red flags for other regulatory bodies (e.g., lack of legitimate medical purpose, improper compounding), it can trigger a broader investigation that includes controlled substance prescribing. The DEA often collaborates with other federal agencies (e.g., HHS-OIG, FDA) and state authorities in healthcare fraud investigations, where the prescribing of any medication, controlled or not, can be a component of a larger scheme.

What This Means For Your Practice

The increased DEA scrutiny on online prescribing of controlled substances, even those not directly scheduled, has significant implications across the healthcare landscape. For telehealth brands, this means a heightened need for robust compliance programs, particularly regarding patient-provider relationships, medical necessity documentation, and adherence to state-specific prescribing laws. The DEA's focus on 'legitimate medical purpose' and 'corresponding responsibility' for prescribers and pharmacies remains paramount, especially in a virtual setting. Telehealth platforms facilitating the prescribing of controlled substances must ensure their workflows prevent diversion and maintain clinical appropriateness. The expectation is that telehealth prescribing should mirror in-person standards of care.

Medspas and weight-loss clinics offering GLP-1 medications, whether in-person or via telehealth, must be acutely aware of the associated regulatory environment. While GLP-1s are not controlled substances, their rapid rise in popularity for weight management has attracted regulatory attention to the prescribing practices surrounding them. This includes ensuring proper patient evaluation, medical necessity, and avoiding off-label promotion. Furthermore, if these practices also involve prescribing controlled substances for other conditions (e.g., anxiety, pain management), the DEA's enhanced enforcement posture directly applies. The potential for state medical boards to follow DEA's lead in scrutinizing these practices is high, often leading to investigations into the legitimacy of the patient-provider relationship and the medical rationale for prescribing.

For dental practices, chiropractic offices, and primary care providers who may utilize telehealth for follow-ups or initial consultations, the message is clear: any prescribing of controlled substances via telehealth must strictly adhere to federal and state regulations. This includes understanding the nuances of the Ryan Haight Act and any state-specific exceptions or requirements for establishing a legitimate patient-provider relationship without an initial in-person exam. Even for non-controlled substances, the DEA's interest in the broader telehealth ecosystem signals a need for all providers to ensure their telehealth practices are clinically sound and legally compliant. The 'corresponding responsibility' doctrine extends to all parties involved in the prescribing process, including pharmacists, who are also under pressure to identify and report suspicious prescriptions.

Ultimately, all healthcare businesses leveraging telehealth must prioritize comprehensive compliance frameworks. This involves regular audits of prescribing practices, robust training for providers on federal and state controlled substance regulations, and clear policies on establishing and maintaining legitimate patient-provider relationships. The DEA's enforcement trends indicate a move towards greater accountability for all stakeholders in the telehealth prescribing chain, emphasizing that convenience cannot supersede patient safety and regulatory adherence. Proactive measures to demonstrate a commitment to legitimate medical practice are essential to mitigate enforcement risk.

Key Compliance Considerations:

• Legitimate Medical Purpose: Every prescription for a controlled substance must be based on a thorough medical evaluation, diagnosis, and treatment plan. Documentation must clearly support the medical necessity.
• Patient-Provider Relationship: Ensure a bona fide patient-provider relationship is established, adhering to federal Ryan Haight Act requirements and any applicable state laws. For controlled substances, this often requires an in-person examination or adherence to specific telehealth exceptions.
• Documentation: Maintain meticulous records of patient evaluations, diagnoses, treatment plans, informed consent, and follow-up care. This is critical for demonstrating compliance.
• State Laws: Be aware of and comply with state-specific regulations regarding telehealth and controlled substance prescribing, which can vary significantly.
• Pharmacist Collaboration: Understand that pharmacists share a 'corresponding responsibility' and may refuse to fill prescriptions they deem suspicious. Foster open communication with pharmacies.
• Training and Policies: Implement ongoing training for all prescribing practitioners on controlled substance regulations and establish clear internal policies for telehealth prescribing.
• Auditing: Regularly audit prescribing practices to identify and address potential compliance gaps.

Conclusion

The DEA's intensified focus on online prescribing underscores a commitment to preventing diversion and ensuring patient safety in the evolving telehealth landscape. While temporary flexibilities remain in place for controlled substances, providers and healthcare businesses must operate with extreme caution and a robust understanding of their regulatory obligations. Proactive compliance and adherence to the highest standards of medical practice are paramount to navigating this complex regulatory environment and mitigating enforcement risk.