DEA Intensifies Scrutiny on Telehealth Prescribing of Controlled Substances, Including GLP-1 Medications
Overview of DEA Enforcement Trends
The Drug Enforcement Administration (DEA) has significantly increased its focus on the online prescribing of controlled substances, a regulatory area that saw substantial flexibilities during the COVID-19 Public Health Emergency (PHE). As the PHE waivers have expired or are in the process of being phased out, the DEA is reasserting its authority under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 and other federal statutes to ensure that controlled substances are prescribed only for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. This renewed emphasis extends to the broader context of telehealth prescribing, including medications like GLP-1s (Glucagon-like Peptide-1 receptor agonists), even though GLP-1s themselves are not controlled substances.
The DEA's concerns stem from the potential for diversion, fraud, and patient harm associated with inappropriate or reckless prescribing practices, particularly those conducted entirely remotely without adequate patient evaluation or a pre-existing patient-practitioner relationship. The agency has signaled that it will closely monitor telehealth providers whose prescribing patterns deviate from established medical standards or raise red flags for illicit activity.
The Ryan Haight Act and Telehealth Prescribing
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (21 U.S.C. § 829(e)) generally requires an in-person medical evaluation before a controlled substance can be prescribed via the internet. During the COVID-19 PHE, the DEA issued waivers that allowed practitioners to prescribe controlled substances via telehealth without a prior in-person medical evaluation, provided certain conditions were met. These waivers were critical in ensuring access to care during the pandemic.
However, with the expiration of the PHE, the DEA has been working to establish permanent rules for telehealth prescribing of controlled substances. The agency initially proposed a set of rules in February 2023, which would have reinstated a modified in-person exam requirement for most controlled substances. Following extensive public comment, the DEA issued temporary rules extending some of the PHE flexibilities, but the long-term direction is clear: the agency intends to tighten controls on fully remote prescribing of controlled substances.
Key aspects of the Ryan Haight Act and DEA's interpretation include:
- Legitimate Medical Purpose: Every 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 is a foundational principle of controlled substance prescribing.
- Bona Fide Patient-Practitioner Relationship: The DEA emphasizes the necessity of a genuine relationship, typically established through an in-person examination, to ensure appropriate medical care and prevent diversion.
- Telemedicine Exception: The Act includes a