PHE Ending - Details Available on New DEA Prescribing Rules Post-Covid-19 PHE

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. 

Background:

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." 

Want to expand your Telemedicine practice safely? Grab your copy of the #1 best-selling book, The Practice of Telemedicine: A Complete Legal Guide for Licensed Healthcare Professionals 

The New Temporary Rule:

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:

• The full set of telemedicine flexibilities regarding prescription of controlled medications as were in place during the COVID-19 PHE will remain in place through November 11, 2023. 
• 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 via 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. 

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:

• First, the prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.
• Second, the prescription must be issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system referred to in 42 CFR 410.78(a)(3)—that is, audio and video equipment permitting two-way, real-time interactive communication or, for prescriptions to treat a mental health disorder – which include, but are not limited to, prescriptions for buprenorphine for opioid use disorder – a two-way, real-time audio-only communication if the distant site physician or practitioner is technically capable of using an interactive audio-video telecommunications system, but the patient is not capable of, or does not consent to, the use of video technology.
• Third, the practitioner must be authorized under their registration under 21 CFR 1301.13(e)(1)(iv) to prescribe the basic class of controlled medications specified on the prescription or exempt from obtaining a registration to dispense controlled medications under 21 U.S.C. 822(d).
• Fourth, the prescription must be consistent with all other requirements of 21 CFR Part 1306.  

What's Next?

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. 

Want to expand your Telemedicine practice safely? Grab your copy of the #1 best-selling book, The Practice of Telemedicine: A Complete Legal Guide for Licensed Healthcare Professionals 

For more on this topic and more legal news for medical professionals, be sure to follow Functional Lawyer on social media and subscribe to our newsletter.