DEA Issues New Proposed Rule on Telehealth Prescribing After the PHE

On Friday, February 24, 2023, the Drug Enforcement Agency (“DEA”) issued long awaited proposed rules for prescribing controlled substances via telehealth after the conclusion of the COVID-19 Public Health Emergency (“PHE”).

The Controlled Substances Act (“CSA”) provides that no controlled substance may be delivered, distributed, or dispensed by means of the internet without a valid prescription. A valid prescription is defined as a prescription issued for a legitimate medical purpose in the usual course of professional practice by either: (i) a practitioner who has conducted at least one in-person medical evaluation of the patient; or (ii) a covering practitioner. Therefore, prior to the PHE, prescribing controlled substances via telehealth in the absence of a prior in-person relationship was limited. At that time, there existed specific categories for prescribing controlled substances via telehealth in compliance with the CSA, including:

  • Telemedicine delivered to a patient that is located in a hospital or clinic
  • Telemedicine conducted during an in-person examination with another practitioner
  • Telemedicine conducted through the Indian Health Service
  • Telemedicine conducted during a public health emergency
  • Telemedicine conducted by a health care practitioner that has obtained special registration for telemedicine
  • Telemedicine conducted during a medical emergency
  • Telemedicine conducted at the discretion of the DEA

Pursuant to the Special Registration for Telemedicine Clarification Act of 2018, the DEA was required to promulgate final regulations concerning the special registration requirements no later than October 24, 2019 to enable practitioners to obtain this special registration to prescribe via telehealth. However, these rules were not issued, and providers have temporarily been availing themselves to the waivers to the in-person prescribing requirement imposed due to the PHE.

With the expiration of the PHE approaching on May 11, 2023, providers prescribing controlled substances via telehealth will lose the protection of the CSA waiver and must reevaluate their prescribing practices.

The DEA’s proposed new rules issued on Friday apply only to telemedicine consultations between providers that have never conducted an in-person encounter with a patient before prescribing a controlled substance. For these encounters, provided that the prescription is otherwise consistent with applicable law, the rules will allow the provider to prescribe in the absence of an in-person relationship:

Importantly, pursuant to the proposed rule, after the initial 30-day supply is ordered, if the provider does not conduct an in-person medical evaluation of the patient (directly or through another provider), (s)he may not issue a subsequent telemedicine prescription to that patient. 

The DEA is seeking public comment on these proposed rules until March 31, 2023 before publishing its final rule. Public comments on this topic must be submitted electronically or via mail with the phrase “Docket No. DEA-407” regarding Schedules III-V and “Docket No. DEA-948” regarding buprenorphine in the subject line.

How Frier Levitt Can Help

Telehealth providers prescribing controlled substances must remain cognizant of the status of this rule and how it may impact their practices. For assistance in the preparation of a comment or more information about how these proposed changes may affect your practice, contact Frier Levitt to speak to an attorney.