Update on Controlled Substances and Telehealth Prescribing
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On June 14th the U.S. Drug Enforcement Agency (DEA) submitted their long-awaited final rule for telehealth prescribing of controlled substances to the White House Office of Management and Budget (OMB) for a final rule before publication. The rules are expected to be published sometime prior to December 2024.
As previously reported, in May 2023 the DEA had temporarily extended the COVID-19 telemedicine flexibilities for prescribing controlled substances. By way of background, The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 requires prescribers to conduct an in-person examination to evaluate each new patient at least once before prescribing a controlled substance. After the federal COVID Public Health Emergency (PHE) was declared in 2020, the in-person requirement was changed to allow prescribers to perform the initial evaluation through real-time videoconferencing. Since then, prescribers have been able to form treatment relationships and prescribe controlled substances to patients whom they have never examined in person.
The revised prescribing rules had been set to expire with the PHE in May 2023; prior to then, in March 2023 the DEA published two proposed rules that would allow limited telehealth prescribing of controlled substances after the PHE expiration. For details on those proposed rules, please see MIEC’s article DEA Announces Proposed Telemedicine Rule Change for Controlled Substances.
Briefly, the proposed rules would have changed the Ryan Haight Act to allow telemedicine-only prescribing after the PHE has ended, but they would have allowed only 30-day prescriptions of certain controlled substances. The proposed rules did not include opioid pain medications or any Schedule II medications, which would still require an in-person visit. The new rules would also have provided a 180-day grace period for remote prescribing relationships formed during the PHE.
In response, significant concern was raised in the healthcare community, including by the American Psychiatric Association, that the new rules would unnecessarily restrict care given that many medical practices had changed to offer only remote care. The DEA solicited public feedback, and over 38,000 comments were submitted largely criticizing the proposed rules. Of the criticisms, stakeholders have focused on the DEA’s failure to institute a telehealth registration system for controlled substance prescribers, as required under the Ryan Haight Act, as well as the proposed restrictions on buprenorphine prescribing for the treatment of addiction.
As a result of the public response, the DEA delayed publication of the new rules and extended the COVID-era flexibilities through the end of 2024 while they finalize and publish the revised rules. While the details of the new rules are unknown, stakeholders are hopeful that the DEA will respond to public feedback by lessening the restrictions on controlled substance prescribing.
Until further information is provided by the DEA, prescribers will be able to continue seeing new patients and prescribing controlled substances without the need for an in-person medical evaluation, as long as the prescriptions are otherwise legitimate and appropriate, and within the course and scope of the prescriber’s medical practice.
Finally, it is very important to note that these requirements only address federal law under the Controlled Substance Act. Additionally, controlled substance prescribers must:
- Ensure that they are properly licensed, or have legal practice authority, in the state in which the patient is physically located at the time of treatment or prescription
- Be aware of and comply with state laws pertaining to controlled substances
- Comply with all applicable standards of care
MIEC will continue to keep our members updated on additional developments on this topic.