The Biden administration recently announced its plans to end the COVID Public Health Emergency (“PHE”) on May 11, 2023. This announcement has left many wondering what this means for the dozens of ketamine telehealth companies that were launched under an exception created by the PHE.
Under the Ryan Haight Act, a controlled substance, such as ketamine, cannot be delivered, distributed, or dispensed using telemedicine technology without a practitioner conducting at least one in-person medical evaluation of the patient. However, the PHE created a temporary exception to this in-person requirement and opened the door for ketamine telehealth companies to provide prescriptions and delivery of ketamine without an in-person medical evaluation. As a result, there was an explosion of ketamine telehealth companies launching over the past few years. For nearly three years, we have seen the federal government renew this PHE with the last renewal extending to April 2023. Now, with the Biden administration announcing the end of the PHE on May 11, 2023, we will revert back to the requirement of an in-person medical evaluation prior to prescribing ketamine to a patient.
So what does this mean for the current ketamine telehealth companies? Undoubtedly, this in-person requirement will heavily impact all ketamine telehealth companies. However, it does not signal the end of all ketamine telehealth companies. While the Ryan Haight Act requires an in-person medical evaluation, it does not have a mandatory requirement of subsequent annual examinations for future prescriptions as long as such prescriptions are issued for a “legitimate medical purpose within the usual course of professional practice.” Arguably, this may mean that a ketamine telehealth company merely needs to have one in-person medical evaluation for the first prescription to a patient and then can use its telehealth platform for future ketamine prescriptions. However, the medical practitioner will need to ensure that such a practice is within the “usual course of professional practice.”
The bigger question, in my opinion, is how many patients will be willing to follow through with the ketamine treatment if the patient is required to have an in-person medical evaluation. During the PHE, ketamine telehealth companies provided patients with the convenience of staying in the comfort of their own homes during the entire process. Now, these patients will need to make doctor appointments; travel to visit the doctor; and deal with the wait times in doctor’s offices. By my approximation, this inconvenience will cause a huge drop-off in patients going through with ketamine treatment, which is unfortunate since I believe ketamine has the potential to heal millions of people suffering from various indications.
Nonetheless, there is still the possibility that the federal government takes action to remove the in-person requirement. When the Ryan Haight Act was originally passed in 2008, the act required that the DEA issue a regulation outlining a special registration process allowing physicians to use telemedicine to prescribe controlled substances without an in-person medical examination. This requirement was reinforced in the SUPPORT ACT. Unfortunately, the DEA has not proposed any new regulations pursuant to the Ryan Haight Act but it is certainly possible the DEA will be motivated to act due to the expiration of the PHE. Additionally, there have been several federal bills seeking to remove the in-person requirement.
Ketamine telehealth companies operate at the intersection of two highly regulated industries: (1) controlled substances; and (2) telehealth. This requires operators to be nimble and resilient. The operators that make the proper adjustments to the PHE expiration will be the winners; the operators that do not make the proper adjustments to the PHE expiration will go out of business. Time will tell which ketamine telehealth companies fall into which category.
About the Author: The author of this article is Dustin Robinson, who is the Managing Principal of Mr. Cannabis Law – a full-service law firm for the cannabis and psychedelic industries. Dustin, through his law firm, has represented various ketamine clinics and other psychedelic businesses. Dustin is also the founder of Iter Investments – a venture capital firm investing in early-stage psychedelic companies, including ketamine clinics; and Mr. Psychedelic Law – a non-profit advocating for legal reform around psychedelics.
Disclaimer: The purpose of this article is to provide general information only and not a solicitation to provide legal services. The information in this article does not constitute or contain formal legal advice or solicitation of legal services. As such, the posting of this article and your reading of this article does not create an attorney-client relationship. This article is also not meant to be a fully exhaustive list of all legal issues relating to ketamine clinics. We highly encourage you to seek legal advice from an attorney if looking to start your own ketamine clinic or otherwise operate in the ketamine space.