On Friday, February 24, 2023, the Drug Enforcement Administration (“DEA”) proposed new regulations that would permanently allow for telemedicine-controlled substance prescriptions, including induction of medication assisted therapy (“MAT”) using buprenorphine. These long-awaited rules will be subject to an accelerated, 30-day notice and comment period that ends March 31, 2023 to allow for implementation prior to May 11, 2023, when the Federal Public Health Emergency (“PHE”) is set to conclude.
The DEA in fact issued two proposed rules: one that addresses telemedicine prescribing generally and another specifically related to telemedicine prescribing of buprenorphine. The proposed rules can be accessed HERE and HERE and would amend DEA regulations to create additional telemedicine flexibilities post-PHE.
We use the term “additional” since these proposed rules do not simply adopt the DEA’s current exception for telemedicine prescribing due to the pandemic. They actually offer greater and permanent telemedicine prescribing flexibility while incorporating strict parameters for telemedicine prescribing. These parameters include limitations on the type and quantity of controlled substances that can be prescribed.
Interested stakeholders will have until March 31, 2023 to submit comments to the DEA. Given the impact of these regulations, interested stakeholders, including health care systems, prescribers and pharmacies, should review the guidance and consider submitting comments to address any unforeseen impacts. Relative to prescribers, questions exist regarding referrals from practitioners who have conducted in-person visits. Relative to pharmacies, note that the telemedicine prescribing standards do not appear to alter a pharmacist’s “corresponding responsibility” to ensure that a course of treatment is properly prescribed.
Detailed Discussion
Current DEA regulations require that a patient receive at least one in-person physical examination by the prescribing practitioner before the provider may prescribe a controlled substance. The Ryan Haight Online Pharmacy Consumer Protection Act makes an exception for certain cross-coverage scenarios, as well as certain instances in which the prescriber is engaged in the “practice of telemedicine.” These telemedicine exceptions, however, are quite narrow (e.g., prescribing to a patient who is physically located in a DEA registered hospital or clinic at the time of the prescription or prescribing to a patient who is in the physical presence of another DEA-registered practitioner at the time of the prescription). These exceptions do not, for example, generally include the ability to prescribe to a patient who is at home when participating in a telemedicine encounter.
This requirement was softened temporarily as a result of the COVID-19 pandemic PHE when the DEA invoked its emergency authority to permit telemedicine prescribing of controlled substances without an in-person physical examination. Specifically, during the PHE that terminates on May 11, 2023, DEA-registered practitioners may issue prescriptions for controlled substances to patients for whom they have not conducted an in-person medical evaluation provided:
- The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice;
- The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communications system; and
- The practitioner is acting in accordance with applicable federal and state law.
If the above three conditions are met and documented, the practitioner may issue the prescription using any of the methods of prescribing currently available and in the manner set forth in the DEA regulations.
With this exception having been in place for nearly three years, many health care entities and providers have operationalized an approach to telemedicine that effectively relies upon this exception. These providers have anxiously awaited clarification regarding these rules with the PHE set to expire. While the DEA’s proposed rules would permanently expand the ability to prescribe through telemedicine, these proposed rules are more restrictive than the current COVID-19 exception.
In addition to reaffirming the need to establish medical necessity by both prescribers and pharmacists, key components of and considerations related to the new rules include:
- A new/additional telemedicine exception to the narrow list of telemedicine exceptions currently in place. Legacy telemedicine prescribing standards remain unaffected.
- The authorization for “telemedicine prescriptions” in situations that include a “qualifying telemedicine referral” by another practitioner. Among other requirements, this would require: i) a physical examination performed in-person by a referring practitioner; ii) compliance with specific documentation requirements; iii) establishing that the prescribing practitioner be physically located within the U.S. or a U.S. territory; and iv) that the prescriber query the pertinent state prescription drug monitoring program (“PDMP”).
- The ability to issue prescriptions for controlled substances with no prior in-person exam or qualifying telemedicine referral provided: i) the prescriptions are limited to a 30-day supply; ii) the relevant PDMPs are queried; iii) the prescribing practitioner be located in the U.S. or a U.S. territory and be licensed in both the originating and distant site locations; iv) only Schedule III through IV controlled substance may be prescribed; and, among other requirements, v) that no Schedule II drugs or opioids are prescribed, except a prescriber may prescribe buprenorphine for opioid use disorder if in compliance with other applicable state and federal law subject to the above 30-day supply limit.
- A provision that will allow a six-month extension for practitioner-patient relationships appropriately established via telemedicine visits during the Federal PHE. Practitioners may continue to prescribe to these patients for the initial six-month period following the conclusion of the PHE. Although the type/quantity limitations noted above do not apply, the new record-keeping requirements related to telemedicine prescriptions do apply to these prescriptions.
Practical Takeaways
Health care providers should review and consider the impact of the significant concepts contained in the DEA’s proposed rules. Similarly, health care entities including both prescriber and pharmacy-oriented organizations should address these rules as part of a comprehensive virtual care compliance plan or policy. Interested stakeholders will have until March 31, 2023 to submit comments to the DEA. A failure to adjust clinical pathways to comply with these new rules, if finalized, may result in significant compliance and professional liability risk for both prescribers and dispensers.
For more information about the DEA’s proposed rules, please contact:
- Chris Eades at (317) 977-1460 or ceades@hallrender.com;
- Todd Nova at (414) 721-0464 or tnova@hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot give legal advice outside of an attorney-client relationship.
