Tele-Prescribing Controlled Substances post-PHE

The federal government has declared that the COVID-19 Public Health Emergency (PHE) expires on 5/11/23.  Many things will occur on that day which I will endeavor to write about in the coming days.  I have many clients and colleagues concerned with rules governing telehealth, so I will focus in my first posting for HLO on what may happen to the rules for tele-prescribing controlled substances post-PHE.  The DEA and HHS jointly proposed rules early in 2023, largely characterized by institutional providers as burdensome and hindering access to care. The sponsoring agencies interpreted the responses to be overwhelmingly in opposition to the proposed rules, and so the proposed rules were abandoned.  The Ryan Haight Act of 2008, established the requirement that the practitioner prescribing controlled substances via the internet must have conducted at least one in-person medical evaluation of the patient, but the option the statute provided of a special registration requirement for telehealth-limited prescribers was also dismissed as too limited.  DEA and HHS have now offered a Temporary Rule to the Office of Management and Budget (OMB) which was available online at federalregister.gov/d/2023-09936 on 5/9/23.  It seems that the agencies heard and acted upon the demand for continued flexibility for these providers and their patients’ needs. That rule provides that “[t]he full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE will remain in place through November 11, 2023.”  In addition, a one-year grace period is established for any practitioner-patient telemedicine relationships established on or before 11/11/23 preserving the “full set of telemedicine flexibilities” in place during the COVID PHE. DEA is evaluating comments and preparing for implementation of final regulations.  The temporary rule, in effect until 11/11/24, adds new 21 C.F.R. 1307.41 and 42 C.F.R. 12.1.