On March 1, 2023, the Drug Enforcement Administration (“DEA”) released two Proposed Rules that, if finalized, would permanently expand the ability of health professionals to prescribe certain controlled substances through telemedicine consultations without a prior in-person visit. The rules are titled “Expansion of Induction of Buprenorphine via Telemedicine Encounter” and “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation.” The rules are intended to continue certain flexibilities established during the COVID-19 public health emergency (“PHE”), currently set to expire on May 11, 2023, and to prevent patients from experiencing lapses in care. Many may view the Proposed Rules as not going far enough, however, especially because they will curtail some existing flexibilities.

The Proposed Rules will apply to the subset of health professionals who have never conducted an in-person evaluation of the patient and whose telemedicine consultation will result in the prescribing of a controlled medication.

Health professionals who fall into this subset will be able to prescribe up to a 30-day supply of two categories of controlled substances without a prior in-person evaluation: (i) a Schedule III, IV, or V non-narcotic controlled medication, and (ii) buprenorphine for the purpose of treating opioid use disorder.

If a refill or continuation is required past 30 days, the patient would need an in-person evaluation. The Proposed Rules offer two alternative options for meeting this requirement: (i) receiving a telemedicine referral from a DEA-registered practitioner who has completed an in-person visit with the patient; or (ii) the prescribing health professional joining a video link to an in-person visit between the patient and another DEA-registered practitioner and virtually attending the in-person examination.

Prior to issuing a prescription via telemedicine, the health professional also will be required to review the Prescription Drug Monitoring Program (“PDMP”) of the state in which the patient is located, in order to both identify and counsel patients of any adverse interactions with the patient’s other medications, and to identify any prior prescriptions and assess the risk of diversion.

The Proposed Rules also require increased record-keeping by prescribing health professionals, with the intention of safeguarding against the risk of diversion. Specifically, health professionals will be required to keep copies of all telemedicine referrals issued or received, maintain a written or electronic log for each prescription issued pursuant to a telemedicine consultation, and maintain documentation of PDMP monitoring. The log must contain the patient’s full name and address along with the date, drug name, strength, dosage, quantity, and directions for use.

It is important to note that all prescriptions of controlled substances still must be made in accordance with state and other federal law. It will be important to check your state’s laws around telemedicine and prescription of controlled substances, as they may be more  restrictive than federal law and policies, and the more restrictive policies will control. It is also important to remember that the health professional must be conducting a bona fide medical evaluation and must be prescribing for a legitimate medical purpose while acting in their usual course of professional practice.

Health professionals should take note of the Proposed Rules and potential impacts on their practices and patients. Although the Proposed Rules are an expansion on pre-PHE policies, current prescribing practices allowed during the PHE will be curtailed. For example, patients needing a prescription for a non-narcotic Schedule III-V controlled substance and who have not had an in-person exam now will be limited to an initial 30-day prescription. With the exception of buprenorphine for treatment of opioid use disorder, patients needing an initial prescription for a narcotic Schedule III-V or Schedule II controlled substance will not be able to obtain one without an in-person exam. Current PHE rules did not impose such limitations. Notably, patients who established telemedicine treatment relationships during the PHE and have current prescriptions for Schedule II-V controlled substances will have an additional 180 days after finalizing of the Proposed Rules to obtain an in-person exam.

The DEA is accepting public comments until March 30, 2023. The comments will be made available for public inspection online. Comments containing confidential information should be submitted in writing and will not be made available for public inspection.

To learn more about the DEA Proposed Rules, please contact a member of Hinckley Allen’s Health Care group.