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New Telemedicine Prescribing Rules Announced by DEA
During the COVID-19 (a.k.a. coronavirus) pandemic, some temporary flexibilities were established. In January 2025, the U.S. Drug Enforcement Administration (DEA) announced plans for three new telemedicine rules to make these flexibilities permanent. The intent is to ensure patients have access to health care and provides some new protections for patients. The three new rules include the following.
Final Rule: Expansion of Schedule III-V Drugs in Treatment via Telemedicine Encounter
The DEA and the Department of Health and Human Services (HHS) have issued a final rule expanding the circumstances under which Schedule III-V medication, such as Buprenorphine (used to treat opioid use disorder), can be prescribed by telemedicine. This also encompasses “an audio-only telemedicine encounter.” The point of the final rule “is to prevent lapses of care by continuing some telemedicine flexibilities that currently exist for those patients seeking treatment for opioid use disorder.” Under the final rule, after a health care provider reviews the patient's data through the Prescription Drug Monitoring Program (PDMP) database for the state in which the patient is located during the telemedicine visit, the health care provider would be permitted to “prescribe an initial six-month supply of such medications (split amongst multiple prescriptions totaling six calendar months) through audio-only means.” After the initial six-month supply, additional prescriptions only can be issued under other authorized forms of telemedicine or after an in-person visit. Prior to filling a prescription, a pharmacist will be required to verify the patient’s identity. This final rule will go into effect on February 18, 2025.
Proposed Rule: Special Registrations for Telemedicine and Limited State Telemedicine Registrations
The DEA issued updated proposed rules which introduce three types of special registrations that will allow medical providers to prescribe medications through telemedicine visits without ever conducting an in-person medical evaluation of the patient. The three types of Special Registration include the:
- Telemedicine Prescribing Registration, authorizing physicians and mid-level providers “to prescribe Schedule III-V controlled substances via telemedicine;”
- Advanced Telemedicine Prescribing Registration, authorizing “qualified specialized clinician practitioners” (including hospice care doctors, psychiatrists, physicians providing treatment at long term care facilities, and pediatricians for the prescribing of medications identified as the most addictive and prone to diversion to the illegal drug market) “to prescribe Schedule II-V controlled substances via telemedicine;” and
- Telemedicine Platform Registration, authorizing “qualified covered online telemedicine platforms, in their capacity as platform practitioners,” to dispense Schedule II-V controlled substances.
In addition to the three types of Special Registrations outlined above, the DEA also is proposing to create another type of special registration, the State Telemedicine Registration, for health care providers who are registered in the state where the patient is located when they receive a prescription for controlled substance over telemedicine for a lower registration fee. Health care providers, under the State Telemedicine Registration for a specific state could only prescribe over telemedicine visits just the scheduled controlled substances for which they are authorized by their Special Registration. Thus practitioners would need registration in each state where they plan to dispense controlled substances by telemedicine. The proposed rules include safeguards such as requiring online telemedicine platforms to register with the DEA and establishing a nationwide PDMP that will provide pharmacists and medical practitioners with visibility of a patient’s prescribed medication history to prevent medication diversion. The rule also provides intensified requirements for recordkeeping, prescription, and reporting Comments on the updated proposed rules must be submitted on or before March 18, 2025.
Final Rule: Continuity of Care via Telemedicine for Veterans Affairs Patients
The DEA and HHS issued a final rule which authorizes U.S. Department of Veterans Affairs (VA) practitioners to prescribe, by telemedicine, controlled substances to a VA patient, even if they were not the professional who conducted in-person medical exam. The practitioner must be acting within the scope of their VA employment. VA medical providers can prescribe controlled substances to patients seen by another VA health care provider in an in-person medical exam, with some restrictions. Under these circumstances, this final rule avoids the need for VA practitioners to obtain a DEA Special Registration (described above) in order to issue prescriptions for controlled substances via telemedicine. This final rule will go into effect on February 18, 2025.
Conclusion
Concerning the scope of these new rules:
- they are not applicable for patients who have been seen in-person by the health care provider.
- patients can be prescribed medication via telemedicine indefinitely by the health care provider who had an in-patient visit with them.
- should medication not be prescribed, then the new rules are not applicable.
- telemedicine visits remain an option for patients.
In summary, the rules are applicable in situations where the patient has not had an in-patient visit with a health care provider and a controlled medicine is being prescribed.
If you have any questions or need further details, please contact Breanne M. Rubin.
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Disclaimer: This alert has been prepared by Eastman & Smith Ltd. for informational purposes only and should not be considered legal advice. This information is not intended to create, and receipt of it does not constitute, an attorney/client relationship.