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The Drug Enforcement Administration (DEA) recently conducted two days of listening sessions, totaling approximately 11 hours, to gather input from stakeholders regarding the future of telehealth prescribing for controlled substances. Key DEA leaders, including Administrator Anne Milgram, Deputy Assistant Administrators Tom Prevoznik and Matthew Strait, participated in the discussions, primarily asking clarifying questions and seeking insights into patient safety, prescription drug diversion prevention, and tracking measures. These sessions were prompted by widespread public opposition to the DEA’s proposed rules on telehealth prescribing, which would reinstate in-person examination requirements for new patients receiving controlled substances.
Background on the DEA’s Proposed Rules
The DEA’s proposed rules, first published in February 2023, aimed to reinstate the requirement that patients undergo an in-person examination before receiving prescriptions for controlled substances via telehealth. This requirement was originally established by the Ryan Haight Act, an amendment to the Controlled Substances Act passed in 2008 to regulate online prescribing. However, due to the COVID-19 public health emergency (PHE), this mandate was temporarily waived to expand access to telehealth services. With the PHE ending in May 2023, the DEA sought to reimplement the in-person examination requirement, though with a limited grace period for patients who began treatment under the pandemic-era telehealth exceptions.
Healthcare providers and telehealth advocates widely criticized the proposed rules, arguing that reimposing in-person requirements would create unnecessary barriers to care, particularly in the midst of the ongoing opioid crisis and nationwide healthcare provider shortages. In response to these concerns, the DEA announced in May that it would delay the implementation of the rules until November 11, 2023, and hold public listening sessions to gather additional feedback on the DEA telehealth regulations.
Key Takeaways from the Listening Sessions
Addressing Misunderstandings About the Proposed Rules
One of the main themes of the listening sessions was the clarification of common misconceptions regarding the proposed DEA telehealth regulations. Matthew Strait, who served as the host for the sessions, emphasized that the rules would not impact cases where a patient-provider relationship had already been established through an in-person exam. He reassured participants that long-standing patient relationships, even those initiated years ago, would not be subject to the new restrictions as long as the patient had been physically examined by their provider at some point.
“This is, I think, a fundamental assumption or perhaps a misunderstanding about our draft rule,” Strait stated on the second day of the listening sessions. “It bears emphasis because we don’t want to lose in our translation the fact that this rule is not being applied broadly to all telemedicine encounters across the entire spectrum, whether that in-person relationship has been established or not.”
Strait reiterated this point multiple times, clarifying that the rules were specifically intended to address new patient relationships where an in-person exam had never taken place. Nonetheless, many presenters and stakeholders remained skeptical about the proposed DEA telehealth regulations and their potential consequences.
Public Commentary and Additional Review
The DEA’s decision to host listening sessions followed an overwhelming response from the public during the initial comment period for the proposed DEA telehealth regulations. The agency received tens of thousands of comments, the majority of which were negative, citing concerns about reduced access to essential medications and disruptions in treatment for patients relying on telehealth services.
During her opening remarks, Administrator Anne Milgram acknowledged the importance of public input and announced that an additional written comment period would be held in the Fall of 2023 before finalizing any telemedicine regulations. While she did not specify a timeline for when final regulations would be issued, the decision to extend the comment process suggests that the DEA is open to potential revisions of the DEA telehealth regulations.
“To those who applied to present today but were not selected, thank you for your interest in this issue, and we’re looking forward to receiving, reviewing and responding to your thoughts as well,” Milgram stated.
Enhancing Data Sharing to Prevent Prescription Drug Diversion
One of the key areas of concern for the DEA during the listening sessions was improving data collection and sharing to track controlled substance prescriptions more effectively. Milgram and Prevoznik asked several presenters about potential strategies for enhancing data reporting from pharmacies, prescribers, and health insurance providers to state and federal agencies. The DEA is particularly focused on preventing prescription drug diversion—the practice of redirecting legally prescribed medications for illicit use.
Some presenters pushed back, arguing that existing regulations already impose strict record-keeping and reporting requirements on controlled substance prescribers. Others highlighted technological challenges, such as the fact that many e-prescribing systems do not currently differentiate between prescriptions issued via telehealth and those issued in person.
Several stakeholders suggested that government-backed health plans, such as Medicare and Medicaid, take on a greater role in controlled substance oversight. Others proposed the creation of a national registry for controlled substance prescriptions or expanding the DEA’s access to state Prescription Drug Monitoring Program (PDMP) databases to improve oversight and coordination across jurisdictions.
Patient Safeguards and Compliance Measures
Another major focus of the listening sessions was ensuring patient compliance and verifying identity in telehealth-based controlled substance treatments. Presenters discussed a range of methods used to monitor patient adherence, including at-home lab testing, virtual check-ins, and biometric verification. However, DEA officials expressed concerns about sample adulteration and the reliability of remote testing methods.
Many addiction treatment professionals emphasized the importance of balancing patient trust with regulatory safeguards. Some suggested that requiring video verification during sample collection could help reduce the risk of fraudulent test results. Others argued that overly stringent monitoring requirements could discourage patients from seeking necessary treatment, particularly those struggling with substance use disorders who may already be hesitant to engage with the healthcare system.
Looking Ahead: What’s Next for Telehealth Prescribing Regulations?
The DEA’s listening sessions provided valuable insight into the complex challenges surrounding telehealth prescribing for controlled substances. While no final decisions have been made, the agency’s willingness to extend the public comment process indicates a potential shift in its approach to DEA telehealth regulations.
For healthcare providers, patients, and advocates, the upcoming written comment period in Fall 2023 represents another opportunity to shape the final DEA telehealth regulations. Key issues remain, including how to balance patient access with the need for oversight, how to improve data-sharing mechanisms, and how to implement safeguards that are both effective and practical.
As the debate over telehealth prescribing regulations continues, the DEA faces the challenge of crafting policies that address both public health concerns and the realities of modern healthcare delivery. The outcome of this process will have significant implications for telehealth providers, patients in need of controlled substance treatments, and the broader effort to combat prescription drug abuse and diversion. In the meantime, stakeholders will be watching closely to see how the DEA’s final regulations evolve in response to ongoing public feedback.
