The Drug Enforcement Administration (DEA) has temporarily relaxed the federal requirements for prescribing buprenorphine for opioid use disorder (OUD) via telemedicine during the COVID-19 public health emergency.
As a general rule, the federal Controlled Substances Act (CSA) requires a valid prescription before a controlled prescription medication may be delivered, distributed, or dispensed by means of the “Internet.”[1] A “valid prescription” includes a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted at least 1 in-person medical evaluation of the patient.[2]
However, the CSA contains several exceptions to the in-person exam requirement when a practitioner is engaged in the delivery, distribution, or dispensing of a controlled substance through the practice of telemedicine.[3] Most notably, an in-person exam is not required if the practice of telemedicine is being conducted during a public health emergency declared by the Secretary of the U.S. Department of Health and Human Services (HHS), and involves patients located in such areas, and such controlled substances, as the Secretary, with the concurrence of the Attorney General (i.e., the DEA), designates.[4]
The DEA has published an information page setting forth the CSA’s requirements for prescribing controlled medications via telemedicine during the public health emergency related to the COVID-19 outbreak. Specifically, prescriptions for controlled medications must be issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice; the telemedicine communication must be conducted using an audio-visual, real-time, two-way interactive communication system; and the practitioner must act in accordance with all applicable federal laws (e.g., HIPAA) and state laws (e.g., state controlled substances acts, laws governing nurse practitioner and physician assistant prescriptive authority).
Recognizing that DATA-waived practitioners often may not be able to reach patients with OUD using audio-visual technology during the COVID-19 outbreak, the DEA posted guidance on March 31 that temporarily relaxes the audio-visual requirement when prescribing buprenorphine for OUD. Specifically, DEA stated that for the duration of the public health emergency (unless DEA specifies an earlier date), DATA-waived “practitioners have flexibility . . . to prescribe buprenorphine to new and existing patients with OUD via telephone . . . without first conducting an examination of the patient in person or via [audio-visual] telemedicine.” At the same time, qualified practitioners must continue to meet their obligation to prescribe only where there is a legitimate medical purpose while acting in the usual course of professional practice.
[1] The term “Internet” means “collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission Control Protocol/Internet Protocol, or any predecessor or successor protocol to such protocol, to communicate information of all kinds by wire or radio.” 21 U.S.C. § 802(50) (2018); 21 U.S.C. § 829(e)(1) (2018).
[2] 21 U.S.C. § 829(e)(2)(A).
[3] 21 U.S.C. § 802(54).
[4] 21 U.S.C. § 802(54)(D).