The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have issued a fourth temporary extension of COVID-era telemedicine prescribing flexibilities for controlled substances, extending key remote prescribing exceptions through December 31, 2026. This extension preserves access to telemedicine prescribing of Schedule II–V controlled medications without requiring an in-person patient evaluation while regulators finalize permanent telemedicine prescribing regulations.
Avoiding the “Telemedicine Cliff”
During the COVID-19 public health emergency (PHE), the DEA and HHS promulgated temporary flexibilities suspending certain in-person evaluation requirements of the Ryan Haight Online Pharmacy Consumer Protection Act (“Ryan Haight Act”), allowing telemedicine practitioners to prescribe controlled substances remotely. These flexibilities have been extended multiple times to avert disruptions in care while permanent policy is developed.
This most recent action, formalized in a Fourth Temporary Rule scheduled for Federal Register publication on December 31, 2025, continues those flexibilities through December 31, 2026, and follows the DEA’s receipt of 6,475 comments in response to its “Special Registrations for Telemedicine and Limited State Telemedicine Registrations” Notice of Proposed Rulemaking issued earlier this year. The fourth extension expressly aims to prevent a “telemedicine cliff” that would result from a sudden cessation of access to care pending promulgation of a final rule pertaining to telemedicine prescribing.
What is the Effect of the 2026 Extension?
Through 2026, DEA-registered practitioners may continue prescribing controlled substances via telemedicine, even in cases where there has not been a prior in-person medical evaluation, provided all conditions of the temporary rule are satisfied. This continues the flexibilities in place since the start of the PHE. The extension gives DEA and HHS additional time to publish permanent regulations governing virtual prescribing of controlled substances, balancing access to care with safeguards against diversion.
Interaction with January 17, 2025 Final Rules
On January 17, 2025, DEA and HHS issued two final rules. After several months of delay, these rules will take effect tomorrow, December 31, 2025: (i) the Expansion of Buprenorphine Treatment via Telemedicine Encounter; and (ii) Continuity of Care via Telemedicine for Veterans Affairs Patients. These rules will operate alongside the Fourth Temporary Rule. Importantly, registrants who qualify under one or both final rules may continue prescribing under the temporary extension through 2026, which in some respects is less restrictive. Key takeaways include:
- The temporary extension is a separate prescribing pathway and may impose fewer requirements than the January 2025 final rules.
- Practitioners may prescribe under the temporary extension even if they also qualify under one or both final rules, so long as the extension’s conditions are met.
- The specific requirements of the final rules apply only when a prescription is issued pursuant to those final rules.
How Frier Levitt Can Help
Despite the temporary extensions and flexibilities, rules surrounding prescribing controlled substances via telehealth remains a complex area of law. The intersection of state-level laws, federal regulations, and DEA policies must be carefully considered in each jurisdiction in which providers are engaged in remote practice. Competent healthcare counsel can assist stakeholders in understanding the nuances of telehealth regulations, including guidance on maintaining patient records, meeting regulatory requirements for data security and privacy, ensuring informed consent, and addressing the limitations on prescribing controlled substances.
As these regulations continue to evolve, it is crucial for healthcare providers, telehealth companies, and other stakeholders to understand their obligations and ensure compliance with both federal and state regulations. Contact Frier Levitt to help navigate the intricacies of your telehealth business practices.
