DEA Proposes Rules to Allow Prescribing Controlled Substances via Telemedicine, Subject to Significant Limitations

Less than one month after the Biden administration’s announcement on January 20, 2023, declaring the end of the public health emergency (PHE) on May 11, 2023, the US Drug Enforcement Administration (DEA) has announced proposed rules¹ (Proposed Rules) to extend certain flexibilities related to prescribing controlled substances via telemedicine that were adopted during the COVID-19 pandemic. As discussed below, the Proposed Rules would not allow the prescribing of controlled substances based on telemedicine interactions to the extent permitted during the PHE. Instead, the Proposed Rules would create a more limited regime that would allow the following:

• prescriptions for up to a 30-day supply of a schedule III, IV, or V controlled substance based on a telemedicine interaction, subject to certain limitations 
• prescriptions for any controlled substance with no limit on the maximum supply of the drug where (1) the prescriber receives a qualifying telemedicine referral from another practitioner who has conducted at least one medical evaluation in the physical presence of the patient; or (2) the prescriber is employed by the Department of Veterans Affairs (VA) and the patient has received an in-person medical evaluation from a practitioner employed by the VA; or (3) the prescriber and the patient have a telemedicine relationship established during the PHE

Background

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act), implemented to regulate online prescribing of controlled substances, generally requires that patients have an in-person medical evaluation with their prescribing practitioner prior to being prescribed controlled substances via telemedicine. Nearly three years ago, at the beginning of the PHE, the DEA announced a waiver to the Ryan Haight Act that provided: 

practitioners in all areas of the United States may issue prescriptions for all schedule II-V controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met:

• 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 communication system; and
• The practitioner is acting in accordance with applicable Federal and State laws.²  

Thus, during the PHE, subject to applicable state law, DEA-registered practitioners could lawfully prescribe controlled substances for legitimate medical purposes following a telemedicine visit without an in-person encounter. The expansion of telemedicine and the DEA’s waiver spurred the growth of a number of businesses that prescribe controlled substances based on telemedicine encounters, including practitioners of substance abuse treatment services, practitioners focused on the treatment of attention deficit disorder, and ketamine clinics.

The DEA’s Proposed Telemedicine Flexibilities

The Proposed Rules maintain some of the flexibilities of the DEA’s original waiver but impose a number of significant limitations on prescribing controlled substances via telemedicine. We review the proposed new regime below.

Prescriptions of Up to a 30-Day Supply of a Schedule III, IV, or V Non-Narcotic Controlled Substance

Under the Proposed Rules, a practitioner may prescribe up to a 30-day supply of a schedule III, IV, or V non-narcotic controlled substance provided that: (1) the prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice; (2) the practitioner is located in the United States; (3) the practitioner is authorized under their DEA registration to prescribe the applicable class of controlled substance, or exempt from registration; and (4) the prescription notes that it has been issued based on a telemedicine encounter. A practitioner may issue multiple prescriptions for a patient. However, the prescriptions cannot authorize the dispensing of more than a 30-day supply of a controlled substance in the aggregate.

Prescriptions Based on a Qualifying Telemedicine Referral, a VA Prescription, or a Telemedicine Relationship Established During the PHE

The Proposed Rules also authorize prescriptions for other controlled substances (such as Schedule II controlled substances) and/or prescribing in excess of a 30-day supply of a controlled substance under the following circumstances: (1) the prescribing practitioner has received a “qualifying telemedicine referral”; (2) the prescriber is employed by the VA, and the prescription is for a VA patient who has received an in-person evaluation from a VA-employed practitioner; or (3) the prescriber has a “telemedicine relationship established during the PHE.”

To meet the standards of a “qualifying telemedicine referral,” the referral must be based on a medical relationship between the referring practitioner and the patient, involving at least one in-person medical evaluation. The in-person medical evaluation need not be exclusively completed by the referring practitioner (i.e., the referring practitioner’s participation in a portion of the medical evaluation is sufficient). The referral must be “for a legitimate medical purpose in the ordinary course” of the referring practitioner’s practice and must include the National Practitioner Identifier (NPI) of the practitioner to whom the referral is being made.³ 

A “telemedicine relationship established during the PHE” means a patient’s relationship with a practitioner that (1) did not involve an in-person medical evaluation of the patient and (2) involved the practitioner’s prescribing of one or more controlled substances based on telemedicine visits during the PHE.⁴  However, this relationship is limited to 180 days from either the effective date of the DEA’s final rule or the end of the PHE, whichever is sooner.

The 30-day limitation on prescriptions for controlled substances issued via telemedicine also is not applicable where a prescription is issued based on an in-person/telemedicine hybrid evaluation where the patient evaluation is performed by a DEA-registered practitioner in the usual course of the practitioner’s practice in accordance with applicable law with a remote prescribing practitioner participating in the evaluation via real-time, audio-video conference.⁵

Requirement to Review PDMP and Requirements for Documentation

Prior to prescribing controlled substances under the Proposed Rules, the prescribing practitioner is required to review data regarding the patient’s prescriptions for controlled substances during the prior year from the applicable state’s Prescription Drug Monitoring Program (if such state has such a program).⁶ The prescriber must note on any prescription for a controlled substance based on a telemedicine consultation that the prescription was issued based on a telemedicine encounter. Practitioners are required to store these and other records that would typically be maintained in a medical record, such as the date the prescription was issued, the name and address of the patient, the location of the practitioner during the encounter, and information concerning the referring practitioner for any qualifying telemedicine referral. Such records must be maintained at the location that the practitioner has registered with the DEA with all such records available at one location.

Prescriptions for Schedule III, IV, or V Narcotic Drugs for Maintenance or Detoxification Treatment

Prescriptions for schedule III, IV, or V narcotic drugs approved by the Food and Drug Administration specifically for maintenance or detoxification treatment, such as buprenorphine, may be issued based on a telemedicine encounter under a regime similar to that described above. Specifically, prescriptions for up to a total 30-day supply are permitted without a prior in-person visit subject to DEA registration requirements, applicable state law, a requirement to check the PDMP, and record-keeping requirements. Prescriptions for more than a 30-day supply of schedule III, IV, or V narcotic drugs approved by the Food and Drug Administration specifically for maintenance or detoxification treatment based on a telemedicine encounter require a qualifying telemedicine referral or an in-person/telemedicine hybrid evaluation. 

What Lies Ahead

The flexibilities provided under the Proposed Rules would create a new regulatory framework for prescribing controlled substances based on a telemedicine encounter. The Proposed Rules would prohibit the prescribing of controlled substances in many circumstances where such prescriptions have been permitted during the PHE. For example, practitioners could not prescribe more than a 30-day supply of a drug or prescribe a schedule II controlled substance such as Adderall or Ritalin without a qualifying telemedicine referral or pursuant to another exception to these limitations.

The preamble to the Proposed Rules solicits comments on certain other potential limitations to prescribing controlled substances, including a limitation on prescriptions for off-label uses. 

The Proposed Rules also do not address DEA registration requirements related to prescribing controlled substances via telemedicine. Once the PHE ends, practitioners prescribing controlled substances via telemedicine will be required to be registered with the DEA both in the state where they are located and in the state where a patient is located to prescribe controlled substances for patients in that state. The DEA has provided limited guidance concerning the requirements for registering in a state when a practitioner will not have any physical presence. A lack of further guidance on this subject may inhibit prescribing controlled substances following the end of the PHE when the current waiver of the requirement for registration in multiple states expires.

The DEA is required by statute to promulgate regulations allowing for the prescription of controlled substances by practitioners pursuant to a special registration. The DEA has never promulgated such regulations. In the preamble to the Proposed Rules, the DEA noted that the Proposed Rules fulfill that requirement. Thus, it appears that the DEA will not be enacting a process to allow the prescribing of controlled substances pursuant to a special registration.

Comments to the Proposed Rules must be submitted electronically or postmarked or submitted on or before March 31, 2023, by 11:59 p.m. ET. 

 

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^[1] Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation, 88 Fed. Reg. 12875 (Mar. 1, 2023) (to be codified at 21 C.F.R. pts. 1300, 1304, 1306), available here: https://www.federalregister.gov/documents/2023/03/01/2023-04248/telemedicine-prescribing-of-controlled-substances-when-the-practitioner-and-the-patient-have-not-had; Expansion of Induction of Buprenorphine via Telemedicine Encounter, 88 Fed. Reg. 12890 (Mar. 1, 2023) (to be codified at 21 C.F.R. pts. 1300, 1304, 1306), available here: https://www.federalregister.gov/documents/2023/03/01/2023-04217/expansion-of-induction-of-buprenorphine-via-telemedicine-encounter. 
^[2] DEA, Diversion Control Division, COVID-19 Information Page, Telehealth (accessed Feb. 28, 2023), available here: https://www.deadiversion.usdoj.gov/coronavirus.html. 
^[3] Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation, 88 Fed. Reg. 12875 (Mar. 1, 2023) (to be codified at 21 C.F.R. § 1304(k).
^[4] Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation, 88 Fed. Reg. 12875 (Mar. 1, 2023) (to be codified at 21 C.F.R. § 1304(o).
^[5] Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation, 88 Fed. Reg. 12875 (Mar. 1, 2023) (to be codified at 21 C.F.R. § 1306.3(d).
^[6] Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation, 88 Fed. Reg. 12875 (Mar. 1, 2023) (to be codified at 21 C.F.R. § 1306.3(d).