On January 15, the Drug Enforcement Administration (DEA) released a proposed rule (.pdf) for special registration related to prescribing controlled substances via telemedicine when the prescribing practitioner has never conducted an in-person medical evaluation of the patient prior to the issuance of the prescription. This rule aims to expand access while maintaining regulatory oversight to ensure safe prescribing practices. Below, are the main provisions of the rule:

Types of Special Registrations

1. Telemedicine Prescribing Registration:
   • Authorizes clinicians to prescribe Schedule III-V controlled substances via telemedicine.
2. Advanced Telemedicine Prescribing Registration*:
   • Allows specialized practitioners (e.g., psychiatrists, hospice physicians) to prescribe Schedule II-V controlled substances via telemedicine.
3. Telemedicine Platform Registration:
   • Requires registration for telemedicine platforms to dispense Schedule II-V controlled substances.

*Specialized Registration Criteria

Advanced Telemedicine Prescribing Registration is limited to:

• Psychiatrists
• Pediatricians
• Neurologists
• Hospice and palliative care physicians
• Board-certified mid-level practitioners specializing in psychiatric, pediatric, neurological, or palliative care

Each type of registration is contingent upon obtaining a State Telemedicine Registration issued by the DEA for every state where the practitioner treats patients, unless exempted. All special registrants would be required to designate one of the registered locations as the point of contact for DEA telemedicine inquiries and compliance actions. Clinician special registrants would be required to establish and maintain photographic records for patient verification and maintain their special registration prescription records at their designated special registered location.

Core Requirements

• Electronic Prescribing: 
  • All prescriptions must be issued through Electronic Prescribing for Controlled Substances (EPCS).
• Prescription Drug Monitoring Program (PDMP) Checks:
  • Initial Three-Year Phase: Clinicians must check PDMPs for:
    • The state or territory where the patient is located.
    • The state or territory where the clinician is located.
    • States or territories with reciprocity agreements.
  • After Three Years: Nationwide PDMP checks will be required for all states, U.S. districts, and territories with PDMP systems.
• Audio-Video Requirement:
  • Prescriptions for controlled substances require both audio and video interactions, except for certain treatments for opioid use disorder (OUD).

The DEA is requesting comments on one or both of the following proposals that would be included in the final rule:

• The first proposal would limit the average number of special registration prescriptions for Schedule II controlled substances to be less than 50 percent of the total number of Schedule II prescriptions issued by the clinician special registrant in their telemedicine and non-telemedicine practice in a calendar month.
• The second proposal would require the special registered clinician to hold both an advanced telemedicine prescribing registration and a state telemedicine registration for that state AND be physically located in the same state when prescribing a schedule II- controlled substance via telemedicine.

Fee Structure

• Special Registration Fee: $888 per type of registration.
• State Telemedicine Registration Fee:
  • $888 per state for platform practitioners.
  • $50 per state for clinician practitioners.

Buprenorphine Treatment via Telemedicine

The DEA has also finalized rules for buprenorphine prescribing:

• Initial Six-Month Supply:
  • Clinicians can prescribe buprenorphine via audio-only or audio-video telemedicine after reviewing PDMP data and recording the review in the patient’s EHR.
  • Prescriptions should be issued incrementally based on medical appropriateness.
• Post-Six-Month Supply:
  • Continued prescribing requires in-person examination or audio-video telemedicine consultations by other forms of telemedicine or practices authorized by the Controlled Substances Act (CSA), or after conducting an in- person medical examination.
• Exceptions:
  • If PDMP data is unavailable, clinicians must annotate this in the EHR and issue renewable seven-day prescriptions while attempting weekly PDMP reviews.

Continuity of Care via Telemedicine for Veterans Affairs Patients

The DEA also finalized a rule regarding the continuity of care via telemedicine for veterans affairs patients (.pdf). The DEA extend telemedicine prescribing authority to VA practitioners to accommodate VA’s unique healthcare infrastructure while safeguarding effective prescribing of controlled substances via telemedicine. This final rule pertains only to VA practitioners prescribing controlled substances to VA patients in circumstances where the prescribing VA practitioner has not conducted an in-person medical evaluation of the VA patient prior to the issuance of the prescription. When VA patients have had an in-person medical evaluation with a VA practitioner previously, this final rule authorizes a different VA practitioner, via the practice of telemedicine, to issue prescriptions for that patient for schedule II-V controlled substances, without being limited to a 30-day supply.

The prescribing VA practitioner must review the VA’s internal prescription database and the PDMP data of the state in which the patient is located during the telemedicine encounter prior to issuing a prescription via telemedicine. It also finalizes the proposed requirement that a prescription for controlled substances be limited to a 7-day supply in situations when either the VA’s internal prescription database or the PDMP data of the state in which the patient is located during the telemedicine encounter is unavailable or non-operational. Once access is restored to the VA patient’s EHR (to include the VA’s internal prescription database) and the PDMP, if one exists for the state where the VA patient is located at the time of the telemedicine encounter, the prescribing practitioner must review the relevant data prior to prescribing an additional supply of the controlled substance, in accordance with the otherwise applicable requirements discussed above. Additionally, the prescribing VA practitioner must annotate the date and time that such a review was attempted in the patient’s EHR and provide a reason as to why a review was unable to be completed. The VA practitioner may then issue a controlled substance prescription in excess of a 7-day supply limit.

Next Steps

APA is actively seeking feedback on these new regulations and will host a listening session February 18 at noon ET to gather input.

Register Here