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The Drug Enforcement Administration on Wednesday issued a long-awaited proposed rule that would create a permanent process for clinicians to more easily prescribe controlled drugs online. The proposal would create a special registration process allowing telehealth doctors and mid-level practitioners to prescribe potentially addictive controlled substances without seeing a patient in person first, as federal law typically requires. Prescribing online without an initial in-person evaluation has been permitted by the DEA since the start of the Covid-19 public health emergency, thanks to several temporary extensions. A number of venture-backed telehealth companies grew rapidly as a result. Most recently, in November, the agency extended this flexibility until the end of 2025, after industry groups sounded the alarm that patients were poised to lose access to needed treatments. The proposed rule would essentially set that flexibility in stone for certain clinicians and add new requirements the DEA says are meant to expand access to care while allowing the agency better oversight. But some industry groups representing health systems, telehealth companies and other organizations that provide online care said the proposed rule may be too restrictive. In a statement, Kyle Zebley, senior vice president of public policy for the American Telemedicine Association, said that the proposed rule looks to contain “elements that represent significant operational challenges.” “All stakeholders need time to carefully review this important proposal, which appears to incorporate valuable elements and other potentially unworkable restrictions that focus on maintaining compliance with patient verification, electronic recordkeeping, and ongoing monitoring,” Zebley said. Meanwhile, the Alliance for Connected Care said it’s concerned that the proposal places limits on what portion of patient care can be offered through telemedicine and the geographies in which telemedicine can be offered. Comments on the rule are due in 60 days. Separately, the DEA and several other federal agencies finalized a rule Wednesday that allows DEA-registered clinicians to prescribe a six-month supply of buprenorphine, a controlled drug used to treat opioid use disorder, without seeing the patient in person. Those clinicians could write the buprenorphine prescription without having a special registration. Notably, the proposed rule discusses the challenges and risks associated with the recent rise of direct-to-consumer, prescription-writing telemedicine platforms. It proposes requiring companies that act as intermediaries in dispensing controlled substances to register with the DEA just like clinicians. “Although the telemedicine flexibilities during the PHE allowing practitioners to prescribe controlled substances without prior in-person medical evaluations were necessary to prevent lapses of care amid a global pandemic, it also facilitated the emergence of concerning business models engaged in the widespread diversion of controlled substances, taking advantage of the flexibilities established during the COVID-19 PHE,” the rule states. Though it doesn’t name any companies in the rule, the DEA last year fined mental health startup Cerebral for encouraging prescriptions of ADHD medications and other controlled drugs. The founder and head clinician of another startup, Done Global, were arrested and charged in June for inappropriate stimulant prescribing, according to the Justice Department. The proposed rule would create three types of special registrations: one for clinicians prescribing Schedule III through V controlled substances , which include anything from testosterone and ketamine to benzodiazepines like Xanax; another for specialized clinicians, such as psychiatrists and hospice care doctors, prescribing those and Schedule II drugs, such as stimulants and pain medication that have a higher risk of addiction and abuse; and one for telemedicine platforms dispensing Schedule II through V controlled substances. Each special registration would last for three years. In addition, the DEA would require clinicians to obtain from the agency another “state telemedicine registration” for every state in which they plan to prescribe controlled substances online. The proposed rule states that clinicians would also be subject to heightened requirements for prescriptions. For example, clinicians would need to check prescription drug monitoring programs (PDMPs) in all 50 states before writing a controlled substance prescription, though that requirement would go into effect three years after the rule is finalized. Before then, clinicians would be required to conduct a more limited PDMP check. The DEA also proposes placing limits on prescriptions for Schedule II controlled substances. It would require that the clinician with a special registration be physically located in the same state as the patient being treated. The proposed rule would also require that the clinician prescribe less than 50% of their average number of monthly prescriptions for Schedule II controlled substances through telemedicine. “Limiting the proportion of Schedule II prescriptions issued through telemedicine would help to manage the risks associated with the prescribing of Schedule II controlled substances by ensuring that a significant portion of these prescriptions are issued following in-person medical evaluations, which can provide a more comprehensive assessment of the patient’s medical history and condition than can be done remotely,” the proposed rule states. (This story is from our Health Tech newsletter. If you’d like to sign up, just click here. )