DEA’s New Proposed Telemedicine Regulations

Provide for a Special Registration (and Other Rules) for Telemedicine

As a follow-up to my article from November 2023, today DEA has proposed a bevy of regulations to authorize the prescribing of controlled pharmaceutical drugs (CPDs) via telemedicine.  Prior to these proposed regulations, The Ryan Haight Act of 2008 required a prescriber have at least one in-person medical evaluation ("in-person requirement") prior to prescribing CPDs to a patient.  The Act allowed for several exceptions to the in-person requirement.  DEA utilized two of those exceptions since March 2020 until now to allow for the prescribing of CPDs via telemedicine.  The Act also provided for a special registration in telemedicine as another exception, but in 16 years DEA had not proposed such a registration- until now.

            The new proposed rule impacts the prescribing of CPDs via telemedicine in four areas: registration, prescriptions, records, and reports.

Registration

            The proposed rule provides for three new telemedicine registrations.  The first is a Telemedicine Prescribing Registration that would allow certain prescribers to prescribe CPDs in Schedules III-V via telemedicine.  The second is an Advanced Telemedicine Prescribing Registration that would allow specialized prescribers, such as psychiatrists and hospice practitioners, to prescribe CPDs in Schedules II-V via telemedicine.  Schedule II CPDs have further restrictions, namely that the prescriber and patient must be located in the same state at the time of the telemedicine encounter and Schedule II telemedicine prescriptions must comprise less than 50% of all Schedule II prescriptions issued by the prescriber monthly.

            With the third registration, DEA takes a novel approach with a Telemedicine Platform Registration.  This registration requires platforms i.e., those businesses that connect patients with remote prescribers, to be registered- the first time DEA is requiring an entity not directly involved in the practice of medicine to be registered in this arena (although DEA argues that such entities are in fact "practitioners.")

            In addition to these special registrations, DEA would also require a State Telemedicine Registration for each state in which the prescriber and their patients are located.  It should be noted that both the current telemedicine flexibilities and these proposed rules require that the telemedicine encounter take place via a real time, two-way audio and video connection (with a few exceptions)- asynchronous encounters do not meet the telemedicine requirement.

Prescriptions

            Any CPD prescriptions authorized under a telemedicine registration would need to be prescribed through electronic prescribing for controlled substances (EPCS), which is specified in other DEA regulations.  The prescriber would also need to verify the identity of the patient and query the patient in the prescription monitoring program (PMP) of i) the state where the prescriber is located, ii) the state where the patient is located, and iii) any states that have a reciprocal PMP agreement where the patient and the prescriber are located.  (DEA is contemplating a requirement to query the PMP on all 50 states within three years of this rule.)

Records

            Prescribers operating under a telemedicine registration would be required to keep records of patient identity verification and of each telemedicine encounter(s).  Platform registrant would be required to maintain records of their prescribers' medical credentials, employment contracts, and any disciplinary action.

Reports

            In addition to maintaining records for inspection, the rule also requires affirmative reporting to DEA of any special registration prescriptions filled by a pharmacy to be reported monthly and yearly reporting from each telemedicine registrant on the number of new patients issued a prescription each month, by state.

            As with any other proposed rule, these rules are not final and must go through the administrative rulemaking process, which includes a public comment period, which for this rule will close on March 17, 2025.  It will be interesting to see if these proposed regulations strike the appropriate balance between access to care and preventing diversion.