United States: DEA Issues Second Temporary Rule Extending Controlled Substance Prescribing Flexibilities Through December 2024

On October 6, 2023, the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) issued a Second Temporary Rule further extending the ability to prescribe controlled substance via telemedicine through the end of 2024.

Key Takeaways

• On November 11, 2023, the Second Temporary Rule takes effect and extends the COVID-19 Public Health Emergency (PHE) telemedicine controlled substance prescribing flexibilities through December 31, 2024.
• The Second Temporary Rule removes the "grace period" established by the previous temporary rule. Instead, it extends telemedicine prescribing flexibilities to all practitioner-patient relationships regardless of when the relationship was established, thereby removing the distinction between new and established telemedicine patients. Under the first temporary rule, only practitioner-patient relationships established prior to November 11, 2023, were granted telemedicine flexibilities for an additional year.
• It is unclear whether the DEA will create a special registration process, which it declined to do through past proposed rules. The special registration process was a key topic at the recent DEA telemedicine listening sessions, which followed DEA's prior comments set forth in the DEA's listening sessions notice. In that notice, the DEA stated they are "open to considering – for some controlled substances" a special registry without in-person requirements, although additional prescribing data collection requirements to prevent diversion would likely be included.
• The DEA continues to review both the 38,000+ comments it received in response to its two February 2023 proposed rules, and the comments and presentations received during the recent DEA telemedicine listening sessions. Further stakeholder commentary may be forthcoming, as DEA announced its intention during the listening sessions to allow an additional comment period regarding its proposed rules.

As a result of the PHE, the DEA granted temporary exceptions to the Ryan Haight Act and the DEA's implementing regulations under 21 U.S.C. 802(54)(D), allowing the prescribing of controlled substances via telemedicine absent an in-person medical evaluation of the patient. These flexibilities authorize practitioners to prescribe schedule II-V controlled substances via audio-video telemedicine encounter. Additionally, practitioners may prescribe schedule III-V narcotic-controlled medications approved by the Food and Drug Administration (FDA) for maintenance and withdrawal management treatment of opioid use disorder via audio-only telemedicine encounters, without requiring an in-person medical evaluation. The DEA extended the "full set" of telemedicine prescribing flexibilities through an initial temporary rule issued on May 10, 2023. The initial temporary rule allows for the prescribing of controlled substances for new patients, absent an initial in-person evaluation, through November 11, 2023; and provides an additional one-year grace period for established telemedicine patients through November 11, 2024. The Second Temporary Rule extends PHE flexibilities through December 31, 2024, for all patients regardless of when the practitioner-patient relationship is established.

The Second Temporary Rule follows a series of telemedicine listening sessions, which the DEA hosted on September 12^th and 13^th in response to wide-spread criticism of its release of two Notices of Proposed Rulemaking (the "proposed rules") in February 2023. The proposed rules stated an intention to reinstate strict limitations on the virtual prescribing of controlled substances and signaled a significant roll back of the in-person medical evaluation flexibilities extended during the PHE. In response, most listening session presenters offered comments in four categories of concern: 1) the telemedicine controlled substance prescribing in-person visit requirement, 2) the proposed thirty-day prescribing limit, 3) proposed reporting requirements (e.g., notating on prescriptions that they were prescribed via telemedicine), and 4) the potential for a telemedicine prescribing special registration process. Provider-specific issues also appeared, including an emphasis on exceptions to DEA requirements applicable to specialized care services like palliative and end-of-life providers. Stakeholder consensus highlighted the industry's desire for a permanent extension of prescribing flexibilities to support patient access to necessary medications without the perceived arbitrary in-person visit requirement.

DEA leadership approached the listening sessions as fact gathering sessions, providing little to no commentary other than to clarify questions. The DEA Administrator Anne Milgram asked questions regarding how the DEA can better use data that providers, pharmacies, and insurers are required to track, maintain, and report. DEA Deputy Assistant Administrator Tom Prevoznik also asked several pointed questions regarding patient identity verification procedures, potentially signaling DEA interest in ensuring accurate address verification of telemedicine patients.

Many stakeholders expressed interest in the creation of a special registration process for remote prescribing, which the 15-year old Ryan Haight Act mandates. Under the Ryan Haight Act, the DEA is required to establish a special registration process for the prescribing of controlled substances via telemedicine. Congress registered its support for the special registration process by delivering a letter addressed to DEA Administrator Anne Milgram on September 13 stating, "[Congress] created a 'special registration' exception, not as an option for DEA to utilize but a requirement to do so" acknowledging that DEA's most recent proposed rules did not meet that obligation. The letter emphasized the potential for a special registration process to balance the need for provider clinical judgement and flexibility in prescribing appropriateness via telemedicine encounters.

During the listening sessions, DEA Administrator Anne Milgram indicated that a forthcoming comment period will take place in the fall of 2023, which will allow for additional written comments before any rules become final. DEA has indicated that it anticipates implementing a final set of regulations related to controlled substance prescribing via telemedicine by the fall of 2024. While the Second Temporary Rule provides additional flexibility for telemedicine companies and practitioners to continue prescribing to patients absent an in-person medical evaluation, it remains unclear whether the DEA will propose to implement similar flexibilities in 2024 on a permanent basis.