On August 4, 2023, the Drug Enforcement Administration (“DEA”) announced plans to host two public listening sessions, scheduled to take place on September 12 and 13, 2023 at DEA’s headquarters in Arlington, VA, to collect additional input regarding the practice of telemedicine and specifically the remote prescribing of controlled substances without conducting an in-person evaluation of patients before prescribing.
The listening sessions will be open to the public, and those who anticipate attending must register through DEA’s Diversion Control website. The registration process opens today (August 7, 2023). DEA also plans to make the listening sessions available via livestream and copies of transcripts from the sessions also will be made available at a later date on the DEA Diversion Control Program website.
Why is DEA poised to listen?
As covered in one of our previous posts, DEA announced proposed permanent rules around prescribing controlled substances via telemedicine in February 2023. The proposed rules were viewed as being more restrictive than the DEA emergency waivers put into place during the COVID-19 public health emergency (“PHE”), but less restrictive in comparison to the pre-PHE regulations applicable to telemedicine prescribing of controlled substances under the federal Controlled Substances Act (“CSA”). The public was invited to submit comments regarding the proposed rules and received more than 38,000 in response. A significant majority of these comments expressed concerns with the proposed rules, citing with respect to at least some controlled substances that the proposed regulations would place limitations on the supply of controlled substances that could be prescribed via telemedicine prior to an in-person medical evaluation. Yet other commenters cited DEA’s long-stated intention to establish a separate Special Registration process for practitioners seeking to prescribe controlled substances via telemedicine without conducting an in-person medical evaluation of patients at all.
However, when the PHE ended on May 11, 2023, DEA instead published a temporary rule in which the agency chose to extend the full set of telemedicine flexibilities adopted during the PHE for an additional six (6) months, through November 11, 2023. For any practitioner-patient telemedicine relationships that have been or will be established up to that date (November 11, 2023), the temporary rule further extends the full set of telemedicine flexibilities for one (1) year, through November 11, 2024. This extension bought the DEA some time to consider and, as DEA Administrator Anne Milgram stated, to “work to find a way forward to give Americans that access with appropriate safeguards.”
How carefully will DEA listen?
DEA’s notice marks a positive change in tone for the agency, which has seemingly resisted creation of a Special Registration process for remote prescribing of controlled substances via telemedicine, even though the creation of such was mandated by Congress through enactment of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Pub. L. 110-425), which amended the federal Controlled Substances Act (21 U.S.C. § 802(54)).
Telemedicine advocates have long argued that health care providers who may engage in prescribing activities per their scopes of practice should be able to prescribe certain medications, including controlled substances, without first needing to conduct an in-person exam of the patient. Advocates have cited the need for this flexibility as a means for expanding access to and treatment for mental health and substance abuse issues, among other reasons. Under the DEA emergency waiver that has been in place since early 2020, flexibilities around the use of remote prescribing have been heavily utilized by health care practitioners. Various members of Congress and prominent advocacy groups have consistently urged the DEA to take action.
How should participants prepare to listen?
DEA has, in announcing the listening sessions, indicated the agency “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.” However, and likely in an effort to set the intended tone for these sessions, DEA also states in the notice 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.”
Helpfully, DEA is asking those who plan to attend the listening sessions to consider the following questions ahead of time:
- 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?
Epstein Becker Green not only will be attending DEA’s September listening sessions but also will be closely following all related news and developments. For additional information about the issues discussed above, or if you have any other telemedicine or digital health concerns, please contact the Epstein Becker Green attorney who regularly handles your legal matters, or one of the authors of this blog post. Read more about our expansive capabilities and offerings here and more generally on EBG’s website at www.ebglaw.com.
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