Welcomed Last Minute Temporary Rule Extends Flexibilities for Controlled Substance Prescribing

You could almost hear the collective sigh of relief from healthcare providers around the country on May 9, 2023.  Two days before the end of the public health emergency (PHE), the Drug Enforcement Agency issued a Temporary Rule that extends current flexibilities for telehealth prescribing of controlled substances for another six months.  The Temporary Rule also provides a one-year grace period through November 11, 2024 for existing patient relationships.

In late February, the DEA announced two proposed rules purporting to extend flexibilities under the Ryan Haight Act for telehealth prescribing of controlled substances.  The proposals, however, offered little flexibility.  And the DEA heard about it – more than 38,000 comments were submitted, many of which detail the harm patients may suffer if the proposed rules are finalized.

The DEA acknowledged that it could not consider all 38,000 comments before the end of the PHE and commenters and others made a compelling enough case that the DEA acted jointly with SAMHSA to extend current flexibilities.  In making the Temporary Rule effective at the end of the PHE, the DEA and SAMHSA jointly concluded that good cause exists to forgo the typically required 30-day delayed effective date.

Here are the highlights from the Temporary Rule:

  • The full set of telehealth flexibilities regarding prescription of controlled medications that were in place during the COVID-19 PHE will remain in place through November 11, 2023.
  • Additionally, for telehealth prescribing relationships established on or before November 11, 2023, the full set of telehealth flexibilities regarding prescription of controlled medications that were in place during the COVID-19 PHE will enjoy a one-year grace period through November 11, 2024.

To take advantage of these flexibilities, certain criteria must be met:

  1. Prescription must be for a valid medical purpose;
  2. The prescription must be issued using an interactive telecommunications system (video) or an audio-only system BUT only if the prescribing provider offers video services, but the patient is not capable or does not consent to the use of video;
  3. Prescriber must be authorized to prescribe the controlled substance; and
  4. Prescription must be consistent with all other requirements applicable to controlled substance prescribing under 21 CFR Part 1306.

While there is a great sense of relief, six months will come and go quickly.  And I suspect that the DEA still will not have waded through the 38,000 comments to its proposed rules.  As a result, providers engaging in telehealth prescribing of controlled substances should start planning now for new patients after November 11, 2023, which will not be subject to these flexibilities.