In an announcement on November 15, 2024, the U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) extended telehealth flexibilities for the prescribing of controlled substances through the end of 2025. This extension ensures providers may continue to deliver care for one more year while a formal, permanent rule is developed.
History of Prescribing Controlled Substances via Telehealth
Pre-COVID
Before the COVID-19 pandemic, pursuant to the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, prescribers were generally prohibited from prescribing controlled substances over the internet without having conducted an in-person examination of a patient. This restriction aimed to prevent the proliferation of “pill mills” and fraudulent online pharmacies, but created significant barriers to care, particularly when overlayed with the growth of telehealth.
During the Pandemic
As a result of the pandemic, the federal government enacted emergency measures to facilitate access to care and telehealth usage, including the temporary relaxation of the in-person examination requirement for prescribing controlled substances, provided certain conditions were met. The emergency waivers also temporarily lifted the requirements for controlled substance prescribers to be registered in the states into which they were prescribing.
DEA’s Proposed Rule
In February 2023, nearing the expiration of the public health emergency, the DEA issued a proposed rule that sought to limit providers to issuing a single 30-day supply of Schedule III-V non-narcotic controlled substances, or buprenorphine for the treatment of opioid use disorder. It proposed that patients would need to undergo at least one in-person evaluation prior to receiving a prescription for controlled substances beyond the short-term period.
However, providers, telehealth companies, and advocacy groups voiced concerns that the proposed restrictions would undermine the accessibility of telehealth. In response to the overwhelming volume of comments, which included more than 38,000 responses—an unprecedented number—the DEA and HHS revisited the proposed rule and extended the Covid-era flexibilities through the end of 2024.
Last-Minute Pressure to Delay the Rule
In August 2024, as the DEA prepared to release its new proposed rule for prescribing controlled substances via telehealth, critics familiar with the rule’s content (which has not yet been made publicly available) argued that the proposed rule was “even worse” than the original proposed rule. As a result, with the looming deadline on prescribing flexibilities quickly approaching, DEA and HHS announced this additional 1-year extension of Covid-19 related waivers through the end of 2025.
The DEA-HHS announcement on November 15—which is expected to be added to the Federal Register by November 19—extending flexibilities through 2025 provides critical benefits to prescribers and telehealth companies, including allowing prescribers to continue prescribing certain controlled substances via telehealth consultations without the need for an in-person visit. The extension is also a critical win for the opioid epidemic response, as it allows prescribers to continue prescribing medication-assisted treatment medications (e.g., buprenorphine) via telehealth consultations.
The DEA has indicated that the additional 1-year extension will enable a smooth transition for both patients and prescribers, who will have more time to evaluate the forthcoming final rules and adjust their prescribing practices accordingly.
How Frier Levitt Can Help
Despite the temporary extensions and flexibilities, 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.
