The U.S. Drug Enforcement Agency Administration (DEA) and U.S. Department of Health and Human Services (HHS) (collectively, the Agencies) on Nov. 11, 2024, issued a third extension of their telemedicine flexibilities for the prescription of controlled substances effective on Jan. 1, 2025. The extension, known as the Third Temporary Rule and codified by amending 21 C.F.R. § 1307.41, allows practitioners to continue prescribing Schedule II-V controlled medications via telemedicine until the end of 2025.
Previous Protections
Prior to the COVID-19 pandemic, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the Act) generally prohibited practitioners from prescribing controlled medications without first evaluating their patients in person. The Act's goal was to prevent the acquisition and abuse of controlled substances by individuals without proper physician supervision and oversight. Notwithstanding the intended purposes of the Act's in-person visit requirements, the pandemic brought significant difficulties for those who needed prescriptions but were unable to safely meet their providers in person. Likewise, states began extending telemedicine requirements to promote access to nonemergency and preventative healthcare services such as medication management services that were commonly provided through routine office visits (the postponement and cancellation of which were hallmarks of the early pandemic) without crowding out facilities that were feeling the strain of providing urgent and emergency healthcare services (services that unavoidably required in-person treatment) during the pandemic.
In March 2020, with the forgoing objectives in mind, the Agencies acted pursuant to an authorized exception in the Act when they jointly promulgated the first set of telemedicine flexibilities that permitted the prescribing of controlled medications without in-person encounters through the use of compliant telemedicine platforms. Since then, the Agencies have extended the same and other flexibilities until the end of 2024, and now through 2025.
Requirements Under the Third Extension
The Third Temporary Rule maintains all of the conditions of the original extensions. In order to permissibly prescribe a Schedule II-V controlled substance via telemedicine in lieu of an in-person visit, the following must be present:
- Legitimate Medical Purpose. The prescription must be issued for a valid, legitimate medical reason in the ordinary course of practice.
- The prescription must be issued pursuant to a communication using an interactive telecommunications system. Audio-visual communication is the standard requirement, with audio-only communication permitted in certain instances of treating a mental health disorder to patients in their homes.1
- Authorized or Exempted Physician. Prescribing physicians must either be authorized under their registration to prescribe such controlled substances2 or exempt from obtaining a registration to dispense controlled substances.3
- Compliance with the remaining regulatory requirements at 21 C.F.R. Part 1306.
Why Keep Extending?
The Agencies cite a number of reasons for the Third Temporary Rule, predominantly focused on maintaining the status quo while they work to develop a final rule or set of regulations that effectively ensures access to telemedicine without compromising the overarching goal of protecting the public health while guarding against risks of diversion. The intent is that patients will continue to have the ability to enter into telemedicine relationships with practitioners while avoiding a potential backlog of in-person medical evaluations by patients who have already entered into telemedicine relationships under the previous flexibility extensions. The Agencies expect that this extension will also afford the necessary time for all parties to properly adjust and come into compliance with whatever permanent regulations may be promulgated in the coming year.
What Does This Mean in the Age of Digital Health?
Since 2020, there has been a rise in the creation and expansion of digital health platforms without any brick-and-mortar component to their businesses. Many of these companies have relied on this extension and the other related telemedicine extensions to support their business models. Only time will tell how the federal government will address these already existing companies, but the extension shows promise for the future of telehealth prescribing. Regulators certainly must consider the market impact on existing telehealth providers when determining any final changes to the Act. As a new presidential administration takes office in 2025, it is unknown whether digital health will be a priority for the Agencies. For the time being, digital health companies should continue business as usual but seek sophisticated legal counsel to ensure compliance with state and federal prescribing requirements.
Holland & Knight continues to watch developments in this area.
Notes
1 42 C.F.R. § 410.78(a)(3).
2 21 C.F.R. § 1301.13(e)(1)(iv).
3 21 U.S.C. § 822(d).
