In response to the large number of public comments received to its recent proposed telemedicine rules,1 the Drug Enforcement Administration (DEA) is holding public listening sessions to consider a special registration for prescribing certain controlled substances via only a telemedicine encounter.
The Big Picture
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) generally requires DEA providers to see a patient in person prior to prescribing any controlled substances, unless a statutory exemption is met. Recognizing the critical need to continue care during the COVID-19 pandemic, providers were temporarily permitted to prescribe certain controlled substances without an in-person visit requirement through the end of the public health emergency (PHE).
In February 2023, DEA published two proposed rules that would end the PHE flexibilities and revert to DEA’s prior requirement that the patient have an in-person evaluation before being prescribed Schedule II medications (which include methadone) and Schedule III–V narcotic medications with limited exceptions. This policy would affect people who are newly prescribed one of these controlled substances after the PHE ends, but also those who began taking such medications during the PHE without an in-person visit. Under the proposed rules, without an in-person visit, a provider would only be permitted to prescribe a 30-day supply of buprenorphine as a medication for opioid use disorder, or of a Schedule III, IV or V nonnarcotic, controlled medication, via telemedicine. In order to extend the prescription beyond the initial 30-day supply, an in-person visit would be required. For a detailed summary of the proposed rules, see DEA Releases Proposed Rules Regarding Telemedicine Prescribing of Controlled Substances. The PHE officially ended on May 11, 2023, but the PHE flexibilities were extended through November 11, 2023, while DEA considered public comments to the proposed rules. The DEA received a combined total of 38,369 comments.
Public Listening Sessions Regarding Telemedicine and Controlled Substances
Due to the high volume of public comments received on the proposed rules, DEA is planning to hear oral presentations from stakeholders in two listening sessions on September 12, 2023, and September 13, 2023. Specifically, DEA is seeking feedback on the following questions during these sessions:
- If telemedicine prescribing of Schedule III–V medications were permitted in the absence of an in-person medical evaluation, what framework, including safeguards and data, with respect to telemedicine prescribing of Schedule III–V medications do you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?
- Should telemedicine prescribing of Schedule II medications never be permitted in the absence of an in-person medical evaluation? Are there any circumstances in which telemedicine prescribing of Schedule II medications should be permitted in the absence of an in-person medical evaluation? If they were permitted, what safeguards with respect to telemedicine prescribing of Schedule II medications specifically would you recommend to help DEA ensure patient safety and prevent diversion of controlled substances?
- If practitioners are required to collect, maintain and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies and other third parties?
- If pharmacies are required to collect, maintain and/or report telemedicine prescription data to DEA, what pieces of data should be included or excluded? What data is already reported to federal and state authorities, insurance companies, and other third parties?
The DEA noted in its announcement of the sessions that telemedicine flexibilities have the potential to expand access to controlled substances while also requiring new accountability frameworks to ensure patient safety and prevent diversion. The decision by the DEA to have these listening sessions appears to signal that DEA is willing to consider a special registration for telemedicine prescribing, for which stakeholders have been advocating for some time as one way to appropriately balance access to care and patient safety.
To present at the listening session, an attendance form (available on DEA’s website) must be submitted and include a summary of the presentation. The form must be submitted by August 21, 2023. DEA will choose presenters at its discretion, based on the person’s or organization’s ability to respond to the specific presented questions and to represent stakeholders on a particular issue.
1 88 Fed. Reg. 12875; 88 Fed. Reg. 12890