The DEA Drug Diversion Control Division sent an email alert on May 15, 2018, reiterating its position on the prescription of controlled substances via telemedicine under the Ryan Haight Act. While simply restating the existing law on the subject, the timing of the notice suggests the agency is clarifying its rules amid various efforts in Congress to amend the law. It remains a possibility that new legislation will accommodate more prescriptions via telemedicine, especially in the context of medication-assisted treatment for opioid addiction and other behavioral health disorders.
The Ryan Haight Act currently allows for controlled substance prescriptions via telemedicine only in certain circumstances, including where the patient is being presented in a DEA-registered hospital or clinic (among other conditions). But this telemedicine exception excludes, for example, non-DEA-registered clinic settings where patients in underserved areas might seek access to a remote provider.
One federal legislative approach is to expedite rule-making around the “special registration for telemedicine” called for under the Ryan Haight Act, which would apply to practitioners. Another proposal is to add “qualified community mental health centers” to the types of facilities that may present patients under the Act’s telemedicine exception.
Here is the full text of the DEA notice:
“Use of Telemedicine While Providing Medication Assisted Treatment (MAT)
Under the Ryan Haight Act of 2008, where controlled substances are prescribed by means of the Internet, the general requirement is that the prescribing Practitioner must have conducted at least one in-person medical evaluation of the patient. U.S.C. § 829(e). However, the Act provides an exception to this requirement. 21 USC § 829 (e)(3)(A). Specifically, a DEA-registered Practitioner acting within the United States is exempt from the requirement of an in-person medical evaluation as a prerequisite to prescribing or otherwise dispensing controlled substances by means of the Internet if the Practitioner is engaged in the practice of telemedicine and is acting in accordance with the requirements of 21 U.S.C. § 802(54).
Under 21 U.S.C. § 802(54)(A),(B), for most (DEA-registered) Practitioners in the United States, including Qualifying Practitioners and Qualifying Other Practitioners (“Medication Assisted Treatment Providers”), who are using FDA approved Schedule III-V controlled substances to treat opioid addiction, the term “practice of telemedicine” means the practice of medicine in accordance with applicable Federal and State laws, by a practitioner (other than a pharmacist) who is at a location remote from the patient, and is communicating with the patient, or health care professional who is treating the patient using a telecommunications system referred to in (42 C.F.R. § 410.78(a)(3)) which practice is being conducted:
A. while the patient is being treated by, and physically located in, a DEA-registered hospital or clinic registered under 21 U.S.C. § 823(f) of this title; and by a practitioner
-who is acting in the usual course of professional practice;
-who is acting in accordance with applicable State law; and
-is registered under 21 U.S.C. § 823 (f) with the DEA in the State in which the patient is located.
OR
B. while the patient is being treated by, and in the physical presence of, a DEA-registered practitioner
-who is acting in the usual course of professional practice;
-who is acting in accordance with applicable State law; and
-is registered under 21 U.S.C. § 823 (f) with the DEA in the State in which the patient is located.
Please be advised that the remote Practitioner engaged in the practice of telemedicine must be registered with the DEA in the state where they are physically located and in every state where their patient(s) is (are) physically located. 21 U.S.C. § 822 (e)(1); 21 C.F.R.§ 1301.12 (a); Notice 69478 Federal Register / Vol. 71, No. 231 / Friday, December 1, 2006.
Also be advised that all records for the prescribing of an FDA approved narcotic for the treatment of opioid addiction need to be kept in accordance with 21 C.F.R. § 1304.03(c), 21 C.F.R. § 1304.21(b), and with all other requirements of 21 C.F.R. Part 1300 to End.
Please note that while this document reflects DEA’s interpretation of the relevant provisions of the Controlled Substances Act (CSA) and DEA regulations, to the extent it goes beyond merely reiterating the text of law or regulations, it does not have the force of law and is not legally binding on registrants. Because this document is not a regulation that has the force of law, it may be rescinded or modified at DEA’s discretion.”
Georgia’s Composite Medical Board is also considering a change to its rule that defines “unprofessional conduct” to include controlled substance prescriptions “based solely on a consultation via electronic means.”
Disclaimer: The foregoing materials are provided for informational purposes only, and are not to be construed as legal advice. Please consult an attorney before applying this guidance to any particular facts or circumstances.