DEA Issues Temporary Rule Extending Flexibilities for Prescribing Controlled Substances via Telemedicine
As a follow up to my email sent last month regarding changes to the federal rules regarding prescribing controlled substances via telemedicine, earlier this week, the Drug Enforcement Administration (DEA) released a temporary rule titled “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications”. The temporary rule was made in response to nearly 39,000 comments the DEA received on their proposed rules regarding what would happen post-public health emergency (PHE) in regards to prescribing of controlled substances via telehealth/telemedicine. The two earlier released proposed rules, one related to non-narcotic controlled substances and one related to buprenorphine, were published on March 1, 2023 with public comment closing on March 31, 2023. The two proposed rules (discussed in my first email) would only allow for the prescribing of a 30-day supply of a non-narcotic controlled substance or buprenorphine. Under the proposed rules, to prescribe beyond 30-days would require at least one of the following: an in-person visit with the prescribing practitioner, a prior in-person referral from another DEA-registered practitioner, or an audio-video visit with another DEA-registered provider present with the patient. The proposals also included a 180-day grace period to meet these requirements for relationships established via telehealth during the PHE. Due to the high number of comments and concerns raised regarding the two proposed rules, the DEA has now issued the current temporary rule.
The temporary rule is issued jointly between the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA) and includes the following:
The full set of telemedicine flexibilities regarding prescription of controlled medications that were in place during the COVID-19 PHE will remain in place through November 11, 2023. In other words, there is no in-person examination requirement prior to the first prescription of a controlled substance so long as a valid practitioner-patient relationship exists and the provider has had an audio-visual visit with the patient.
Additionally, for any practitioner-patient telemedicine relationships that have been or will be established on or before November 11, 2023, the full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE will continue to be permitted for a one-year grace period through November 11, 2024. In other words, if a patient and a practitioner have established a telemedicine relationship on or before November 11, 2023, the same telemedicine flexibilities that have governed the relationship to that point are permitted until November 11, 2024.
The temporary rule is to go into effect on May 12, 2023 (the first day after the PHE expires) and will expire at the end of the day on November 11, 2024. The COVID prescribing flexibilities for telehealth, which include only seeing patients via telehealth and the ability to prescribe buprenorphine based on an audio-only interaction, are only extended for an additional six months under this temporary rule. What that means is that telehealth providers may still prescribe controlled substances during this time without having had an in-person exam with the patient and a patient-provider relationship can be established in this way. However, this is only for six months after the end of the PHE. Afterwards, if a telehealth provider established a relationship with a patient during the COVID PHE and in the six-month post-PHE grace period, they may continue to prescribe without having met that in-person exam requirement for an additional year (until November 11, 2024). This additional one-year grace period from November 12, 2023 to November 11, 2024 is meant to give practitioners 12 months to meet that in-person exam requirement. For new patients having an initial visit after November 11, 2023, there will likely be additional requirements forthcoming pending the DEA’s release of a final rule.
In the comment section of the temporary rule, the DEA notes they were deliberate in their choice of timing. While they were trying to avoid practitioners being inundated with trying to meet the in-person visit requirement in a short period of time right when the PHE is ending, they also did not wish to create too long of a grace period. They said that “[b]y only extending the flexibilities for a short period, the six-month extension would be unlikely to incentivize the investment necessary to develop new telemedicine companies that might encourage or enable problematic prescribing practices.”
The DEA does state that final regulations for prescribing via telehealth will be made, but this temporary stay will be in place as that is being worked upon.
As always, I will keep you posted if I learn of new information.
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Stephanie Berg Law PC