The Drug Enforcement Administration is preparing to release its final rule for telehealth and controlled substances.
On Thursday, the White House’s Office of Management and Budget (OMB) received the final rule from the DEA. The OMB oversees the coordination and review of major executive branch actions. It’s the final stop before the final rules are published.
The rule itself has not been released. It’s unclear when that will happen.
The release of the final rule would present the next evolution in establishing a post-COVID paradigm for the use of telehealth in prescribing controlled substances.
In March 2023, the DEA published two interrelated rules. They re-established rules that require controlled substances categorized under the DEA’s Schedule II through V to be prescribed only after an in-person examination, among other regs. This would effectively end or complicate the virtual-only approach to behavioral health where such medications are relevant, especially when it comes to virtual medication-assisted treatment (MAT) for opioid use disorders (OUD).
The comment period saw a crush of largely negative feedback from the public. By May 2023, the DEA announced the first of two delays to releasing a final rule on controlled substances and telehealth. In September 2023, the DEA held two days of listening sessions where industry advocates could give testimony, submit data and engage in public questioning with high-level DEA leaders. A few weeks later, the agency announced the second delay in the final rule. The second delay extended the flexibilities for telehealth and controlled substances until December 2024.
“The purpose of this second temporary rule, like the one before it, is to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as allowing adequate time for providers to come into compliance with any new standards or safeguards,” the DEA said in the temporary rule enacting the second delay. “DEA is working to promulgate new standards or safeguards by the fall of 2024.”
The proposed rules essentially eliminate telehealth-only prescribing for Schedule III to V narcotic and Schedule II non-narcotic controlled substances without a prior in-person examination. There are narrow exceptions for time-limited supplies of non-narcotic drugs and buprenorphine, a popular drug used to treat opioid-use disorder (OUD) before an in-person exam is administered.
The timing of the submission comes just after the DEA and a coalition of federal agencies revealed that they were pursuing a criminal investigation of the virtual ADHD treatment provider Done Global. That investigation has now progressed to a criminal prosecution with the arrest of Done Global’s ex-CEO and co-founder as well as its top clinical executive.
Many in the behavioral health and virtual care space have expressed fear that unscrupulous operators such as Done Global — as well as, to some extent, the once-meteoric startup Cerebral — would give regulators skeptical of what they see as easier access to potential dangerous drugs the justification they need to revert federal policy to a pre-COVID paradigm.
Several digital behavioral health companies, especially addiction treatment companies, flourished in the more permissive regulatory environment. In some ways, they contributed to and benefited from a rush of venture capital into the space that has since fallen off.
“The defendants (Done Global executives) allegedly preyed on Americans and put profits over patients by exploiting telemedicine rules that facilitated access to medications during the unprecedented COVID-19 public health emergency, instead of properly addressing medical needs, the defendants allegedly made millions of dollars by pushing addictive medications,” DEA Administrator Anne Milgram said in a statement. “The DEA will continue to hold accountable anyone, including company executives, that uses telehealth platforms to put profit above patient safety.”
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