On October 6, 2023, the DEA and SAMHSA issued a temporary rule that will extend the full set of telemedicine flexibilities adopted during the PHE through December 31, 2024. This extension, which follows an earlier temporary rule issued in May 2023, authorizes all DEA-registered practitioners to prescribe schedule II-V controlled medications via telemedicine through December 31, 2024, regardless of when the practitioner-patient relationship was established. (Under the May 2023 temporary rule, the extension allowed the prescription of a controlled substance without a previous in-person examination only for relationships established on or before November 11, 2023, and only until November 11, 2024.)

BACKGROUND

Under the Ryan Haight Act of 2008, a telemedicine provider was first required to perform an in-person medical evaluation of a patient prior to prescribing a controlled substance (with certain limited exceptions). The controlled substance-prescribing flexibilities invoked in March 2020 in response to the PHE, which allowed for prescribing controlled substances via telemedicine without an initial in-person visit, were set to end with the termination of the PHE on May 11, 2023.

In February 2023, the DEA and SAMHSA proposed two rules (the General Telemedicine Rule and the Buprenorphine Rule), which would have established additional potential pathways for prescribing certain controlled substances in limited quantities via telemedicine without an initial in-person medical examination, while also imposing detailed recordkeeping requirements.

Notably absent from the proposed rules was a “special registration” process. Under the Ryan Haight Act, a prior in-person medical evaluation is not required if the practitioner holds a special registration. However, in the 14 years since the act’s passage, the DEA has failed to establish the special registration process for qualified providers (even though Congress imposed a deadline of October 2019 in the 2018 SUPPORT for Patients and Communities Act (SUPPORT Act) for the promulgation of final regulations for the special registration process). In the proposed rules, the DEA opted not to implement the special registration process and instead invoked its authority under a different provision of the Ryan Haight Act. (See our Special Report: DEA Proposes Limited Post-PHE Telemedicine Prescription of Controlled Substances for more details on the proposed rules.)

The DEA received a record 38,000 comments in response to the proposed telemedicine rules, including comments from federal lawmakers. Many stakeholders pointed out that the requirement for an in-person evaluation would make it more challenging for certain patients facing significant barriers to accessing care without telemedicine to continue receiving the controlled medications they need. Subsequently, the DEA issued the May 2023 temporary rule, extending telemedicine flexibilities adopted during the PHE through November 11, 2023, for new patients, and November 11, 2024, for patients established on or before November 11, 2023. It also indicated that it would be further evaluating its proposed telemedicine rules in light of the comments.

DEA LISTENING SESSIONS

The October 2023 temporary rule comes on the heels of a two-day listening session in which the DEA heard from healthcare practitioners, experts, advocates, patients and other members of the public regarding the prescription of controlled substances via telemedicine, along with potential safeguards to prevent and detect the diversion of controlled substances prescribed via telemedicine.

Sixty-one commenters spoke during the session. Key themes:

• Commenters were largely supportive of a special registration for telemedicine prescription of schedule II-V controlled substances, although no best practice emerged.
• Pharmacists were concerned they would bear the brunt of burdensome checks and data collection for the new regulations.
• Palliative-care and end-of-life advocates requested an exemption to the in-person requirement for those in hospice or similar end-of-life care.
• There was no consensus among the commenters on the in-person prescription requirement. Several of them emphasized that the prescribing of controlled substances via telemedicine during the PHE increased access to care and decreased relapse rates, particularly for patients seeking treatment for substance-use disorders. These commenters generally stated that in-person visits are not necessary and that providers should use their medical judgment in determining when an in-person visit would be indicated. Other commenters argued that an initial in-person visit should be required and expressed concerns about the diversion of controlled substances.
• Overall, the commenters agreed that regulations should not increase practitioner burden and that the DEA should leverage data from existing sources to monitor telemedicine prescribing practices. Some commenters suggested that the DEA consider establishing a national prescription drug monitoring program.

Lawmakers have also been following this issue closely. After the listening session, a bipartisan group of senators wrote to the DEA, expressing concerns with the current proposed rule and imploring the DEA to create a special registration process. They cited the SUPPORT Act’s requirement and noted that the goal of the special registration is to allow medical evaluations over telehealth more broadly, which the senators stated the proposed rule does not accomplish. The DEA’s actions will continue to be closely scrutinized by policymakers.

WHAT’S NEXT?

The DEA has extended the telemedicine flexibilities adopted during the PHE through December 31, 2024, and will continue to evaluate the information it received during the listening session, as well as the 38,000 comments on the proposed rules. The DEA anticipates releasing a final rule in fall 2024. During the listening session, the DEA indicated there may also be another written comment period this fall.

Additional Authors: Amanda  Enyeart, Jayda  Greco, Rachel Stauffer |