The US Drug Enforcement Administration (DEA) issued a temporary rule on October 6, 2023 extending COVID-19–era flexibilities through December 31, 2024. With this extension, the DEA will continue to waive provisions under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 that prohibit practitioners from prescribing controlled substances to patients without first conducting an in-person encounter.
DEA’s Regulatory Pressures
The news of the rule’s extension arrives on the back of a recent public listening session in which the DEA heard commentary from various provider, advocacy, and patient stakeholders, among others, regarding their concerns over the DEA’s proposed final rule released in March 2023. The proposed final rule would claw back much of the flexibility allotted during the Public Health Emergency (PHE) and would, in effect, push the practice of telehealth back to pre-PHE times.
Specifically, the proposed rule would largely restrict healthcare providers from prescribing controlled substances through virtual encounters by either
- limiting prescribers to a single fill of a controlled substance without an in-person visit; or
- requiring a complex series of referrals from another in-person practitioner before the prescriber could issue a prescription via electronic means.
The rule’s publication drew significant opposition from the provider stakeholder community, with the DEA receiving more than 38,000 comments in response, most of which scrutinized DEA’s perceived shortsightedness and burdensome requirements for typical prescribing relationships. As a result, the DEA was pressured to keep the status quo until November 11, 2023 while it heard from stakeholders and took the impact of the proposed rule into further consideration.
Now, with this additional perspective in hand, the DEA appears to be going back to the drawing board to further revise the final rule to balance providers’ concerns with the need to ensure that controlled substances are appropriately prescribed and monitored.
Alternative Legislative Strategies
In addition to the onslaught of provider comments, the DEA’s additional reprieve may have also resulted, in part, from mounting congressional pressure. In a bipartisan letter sent to the DEA in September 2023, several senators expressed concerns over both the potential impact of the DEA’s proposed rule and the fact that the DEA has yet to develop a special registration process for teleprescribing despite multiple legislative actions permitting, and in fact requiring, it to do so.
As envisioned by the US Congress, the special registration process would allow registered healthcare providers to use their clinical judgment to determine when a medical examination may be conducted via telehealth—as opposed to in person—for the purposes of prescribing controlled substances.
However, in addition to the special registration process, there are a number of potential tools the DEA might consider for mitigating abuse and diversion of controlled substances while still promoting access to appropriate medical interventions. In particular, utilization of a federalized prescription drug monitoring program (PDMP) could help both the DEA and prescriber and pharmacy stakeholders identify bad actors and limit the extent of illicit prescribing patterns in which they engage.
As it stands now, while 49 of the 50 states have PDMPs, these state-level PDMPs do not effectively communicate with each other or DEA authorities. Coupled with a special registration process that would certify certain prescribers that have demonstrated a level of trust in virtual prescribing behavior, the implementation of a federalized PDMP would enable the DEA to promote teleprescribing while keeping controlled substances out of the hands of unauthorized individuals.
Looking Ahead
While the temporary rule’s extension may be viewed as a boon for telehealth providers, it remains to be seen how, if at all, the DEA will modify its initial proposal. Accordingly, providers should keep a close eye on developments published by the DEA throughout the next year to understand what their obligations may be in 2025 and thereafter.