The United States Drug Enforcement Administration (DEA) announced that it is seeking public input “concerning the practice of telemedicine with regards to controlled substances and potential safeguards that could effectively prevent and detect diversion of controlled substances prescribed via telemedicine.” To that end, the DEA will host two listening sessions: one on Tuesday, September 12, 2023, and another on Wednesday, September 13, 2023, from 9:00 am – 5:30 pm.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires that a prescribing practitioner (with certain exceptions) may only prescribe controlled substances to a patient if they have, at some point, performed an in-person evaluation of the patient. Once a provider has conducted at least one in-person medical evaluation, the Ryan Haight Act does not prohibit the practitioner from prescribing controlled substances.
During the COVID-19 Public Health Emergency, the DEA granted temporary exceptions to the Ryan Haight Act and the DEA’s implementing regulations, allowing the prescribing of controlled substances via telemedicine, irrespective of whether the provider has ever conducted an in-person medical evaluation. The DEA again extended that waiver to avoid lapses in patient care.
Since then, and prior to the expiration of the COVID-19 PHE, the DEA and HHS promulgated two notices of proposed rulemaking in the Federal Register that sought to expand patient access to controlled substance prescriptions via telemedicine while also maintaining effective controls against diversion. The DEA received 38,369 responses to the two NPRMs – among the highest number of public comments received on an NPRM in the DEA’s history.
Most of the comments expressed concern that the NPRMs placed limitations on the supply of controlled substances that could be prescribed via telemedicine before an in-person medical evaluation. Several hundred comments specifically raised the possibility of a separate Special Registration for practitioners who seek to prescribe controlled substances without conducting an in-person medical evaluation of patients at all.
The DEA is open to considering implementation of a Special Registration for telemedicine prescribing for patients without requiring the patient to ever have had an in-person medical evaluation at all. The agency is also considering that making some telemedicine flexibilities permanent would potentially create a new framework for medicine that expands access to controlled substances in a way that would necessitate a new framework for accountability based, in part, on increased data collection and visibility into prescription practices in order to ensure patient safety and prevent diversion in near-real-time. Before the DEA makes any decisions, the agency would like to gather additional information first.
Therefore, during the listening sessions, the DEA is specifically seeking input from interested individuals, including medical practitioners, patients, pharmacy professionals, industry members, law enforcement, and other third parties, focused on the following topics:
- advisability of permitting telemedicine prescribing of certain controlled substances without any in-person medical evaluation at all,
- the availability and types of data that would be useful in detecting diversion of controlled substances via telemedicine that are either already reported or could be reported, and
- specific additional safeguards that could be placed around the prescribing of schedule II controlled substances via telemedicine.
The DEA requested that those wishing to give an oral presentation at the listening session pre-register and will review those requests to select a cross-section of persons and organizations to present at the listening sessions.
The listening sessions will be live streamed online. Interested parties who wanted to attend in person needed to have pre-registered with the DEA by August 21.