An In-Depth Look at Telemedicine Regulations and Prescribing Controlled Drugs

“For three years, telemedicine providers have prescribed controlled drugs without in-person exams. When the COVID-19 public health emergency ends in May, the rules will change.

Under new federal regulations proposed to take effect in May, tens of thousands of patients across the U.S. will need to schedule in-person visits to continue obtaining prescriptions for controlled drugs via telemedicine.

Patients being treated remotely with buprenorphine for opioid use disorder, Ritalin for attention deficit disorders, ketamine for depression, or testosterone for gender-affirming care, among other controlled-drug treatments, will need to schedule an in-person exam, either with their telemedicine prescriber or a local provider who is registered with the federal Drug Enforcement Administration, according to the DEA’s proposed rules.

The draft regulations, which were first announced Feb. 24, allow telemedicine providers to initially prescribe 30 days’ worth of some medications, including buprenorphine, testosterone, or ketamine, before an in-person exam is required. Patients taking narcotic pain medication, or common ADD medicines, however, will need an in-person exam before any new prescriptions can be issued. Patients and providers who established treatment relationships remotely during the pandemic, when in-person exam requirements were temporarily waived, would have 180 days to comply with the new laws.

A brief history of online drug prescription regulations

The federal regulation of online prescribing started with the 2008 passage of The Ryan Haight Online Pharmacy Consumer Protection Act, which was meant to combat rogue internet pharmacies that started selling controlled drugs online in the 1990s. The law generally required in-person medical evaluations prior to prescribing controlled substances, but carved out seven exceptions, including one for public health emergencies, such as the COVID-19 pandemic. Thus, for the past three years, telemedicine practitioners have been prescribing controlled drugs without needing to conduct in-person exams. With the pandemic public health emergency ending in May, this exemption will no longer stand.

Another exception in the 2008 law envisioned the creation of a “special registration” process through which qualified telemedicine providers could prescribe controlled drugs without in-person visits. The DEA did not create the registration process at the time but was again directed to establish it in the SUPPORT Act of 2018. As a result, most stakeholders were expecting the DEA to enact the formal registry this year.

Instead, the DEA surprised the medical, telehealth, and health policy communities by proposing a narrow set of regulations aimed at improving access to buprenorphine, an effective medication used in opioid addiction treatment, while curtailing improper prescribing and illegal diversion of controlled drugs.”

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Originally published by The Journalist's Resource