The agency will meet in September with interested parties to discuss a long-debated proposed registration for providers wishing to prescribe controlled substances via telemedicine without first conducting an in-person exam.
The US Drug Enforcement Administration may finally be open to giving healthcare providers more freedom to prescribe controlled substances via telemedicine.
The DEA has scheduled two public listening sessions, to take place on September 12 and 13, to discuss creating a special registration for providers who want to prescribe controlled substances without first conducting an in-person evaluation.
The notice marks a change in tone for the agency, which has long resisted creating that registration process even though it was mandated by Congress in 2008 through the Ryan Haight Online Pharmacy Consumer Protection Act. Telehealth advocates have long argued that providers should be able to prescribe certain medications without first needing an in-person exam as a way of expanding access to and treatment for mental health and substance abuse issues. Several members of Congress and the American Hospital Association have also chimed in, urging the DEA to take action.
Relaxed rules for prescribing controlled substances via telemedicine were included in waivers put in place during the COVID-19 Public Health Emergency, but the PHE ended in May. The DEA proposed a new set of rules set to take place after the PHE, then backtracked and extended the waiver for six months after those new rules drew strong criticism.
"Among the 38,369 comments submitted in response to the [proposed new rules] a significant majority expressed concern, with respect to at least some controlled substances, that the proposed regulations placed limitations on the supply of controlled substances that could be prescribed via telemedicine prior to an in-person medical evaluation," the DEA said in its meeting notice. "In addition, several hundred comments specifically raised the possibility of a separate Special Registration for those practitioners who seek to prescribe controlled substances without conducting an in-person medical evaluation of patients at all."
"DEA is open to considering—for some controlled substances—implementation of a separate Special Registration for telemedicine prescribing for patients without requiring the patient to ever have had an in-person medical evaluation at all," the agency continued. "DEA also observes that making permanent some telemedicine flexibilities on a routine and large-scale basis would potentially create a new framework for medicine that fundamentally expands access to controlled substances in a way that warrants 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."
With that in mind, the agency is asking those attending the upcoming meetings to consider the following questions:
- 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 the agency 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 it were permitted, what safeguards with respect to telemedicine prescribing of schedule II medications specifically would you recommend to help the agency 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?
Eric Wicklund is the associate content manager and senior editor for Innovation at HealthLeaders.
KEY TAKEAWAYS
Federal regulations in place since 2008 severely restrict the prescription of controlled substances, and in limited instances those medications can be prescribed by telemedicine if the provider first conducts an in-person exam of the patient.
Telehealth advocates have long argued that providers should be able to prescribe certain drugs via telemedicine without that in-person exam, saying that would expand much-needed programs for mental health and substance abuse treatment.
The DEA has long resisted creating a special registration for providers wishing to prescribe controlled substances via telemedicine, but may be softening its stance.