In order to avoid lapses in care for patients, the Drug Enforcement Administration (DEA) announced an extension of the temporary Covid-era exceptions to the Ryan Haight Act requirements for prescribing controlled substances.
In the text of the new rule published May 10, 2023, which you can read in full here, DEA puts forth the details of the new, temporary rule that extends prescribing flexibilities.
Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Ryan Haight Act), in-person evaluation, conducted by the prescriber, is required before any controlled substances may be prescribed, with very limited exceptions.
One of those exceptions under the Ryan Haight Act includes public health emergencies declared by the Secretary of Health and Human Services (HHS). With the federal Covid-19 public health emergency (PHE) set to expire May 11, 2023, the DEA needed to address the real-world implications of ending an exception so abruptly, creating what many are calling a “prescribing cliff” for patients and providers who have come to rely on the PHE exception.
Their first attempt to ramp down the PHE exceptions was met with record pushback from provider groups, patient advocates, hospital associations and other industry stakeholders. On March 1, 2023, DEA, ain concert with HHS, promulgated two notices of proposed rulemakings (NPRMs) in the Federal Register that sought to make permanent some of the telemedicine flexibilities established during the COVID-19 PHE. The stated goal was to facilitate patient access to controlled medications via telemedicine when consistent with public health and safety, while maintaining effective controls against diversion.
In a statement released May 3, 2023, DEA acknowledged that it received a record number of comments from industry stakeholders and policymakers during the public comment period for its proposed rules. They noted, "We recognize the importance of telemedicine in providing Americans with access to needed medications, and we have decided to extend the current flexibilities while we work to find a way forward to give Americans that access with appropriate safeguards."
DEA, jointly with the Substance Abuse and Mental Health Services Administration (SAMHSA), is issuing a temporary rule to extend certain exceptions to existing DEA regulations.
While the language of the rule is more technical, here are the effects:
Keep in mind that all prescriptions issued under these exceptions are still subject to continuing requirements, including the requirements that were in place during the COVID-19 PHE:
Through this extension, DEA bought itself time to review public comments on its first attempt at rulemaking, and evaluate how to balance the needs for patient continuity of care with its mission to prevent diversion. As this temporary rule is scheduled to sunset, DEA anticipates the implementation of a final set of regulations permitting the practice of telemedicine under circumstances that are consistent with public health, safety, and effective controls against diversion. The stated goal of this temporary rule is to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as to allow adequate time for providers to come into compliance with any new standards or safeguards that DEA and/or SAMHSA promulgate in one or more final rules.
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