DEA Proposes New Telemedicine Regulations
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Act) amended the Controlled Substances Act (CSA) in an attempt to prevent the illegal distribution of controlled substances on the internet. Among other things, the Act required an in-person medical evaluation as a prerequisite to prescribing or otherwise dispensing controlled substances online. One exception allowed DEA to waive the in-person requirement during the COVID Public Health Emergency (PHE). During the pandemic a number of companies began providing a not insignificant volume of controlled substances via telehealth, namely ketamine and Adderall, subject to this exception. However, that exception is set to expire on May 11, 2023, thrusting a nascent industry into uncertainty over the past few months. Analysts familiar with DEA’s intransigence and stall tactics predicted that the ketamine telehealth industry would be devastated by the expiration of the PHE declaration. In a surprise to most, on March 1, 2023, DEA issued a notice of rulemaking that would authorize telemedicine where 1) the prescribing practitioner has not conducted an in-person medical evaluation with the patient; 2) the prescription was issued pursuant to a telemedicine encounter and 3) the telemedicine encounter results in a prescription for controlled medications. There are some limitations, including that prescribing practitioners will only be able to issue telehealth prescriptions for up to a 30-day supply of a controlled substance, and there are labeling and recordkeeping requirements. Some telehealth providers and advocates have concerns about some of the limitations in the DEA’s proposed rules, but for ketamine in general, “this is an encouraging development from an agency that has earned a reputation for being dilatory and obstructionist at times”, says Emerge Of Counsel attorney, Matt Brockmeier.