What's up with Telemedicine Prescribing of Controlled Substances?
May 2023 Update: On May 9, 2023, the Drug Enforcement Agency (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) announced the temporary extension of flexibilities around telemedicine prescribing of controlled substances from the COVID-19 public health emergency (PHE). This extension will allow time for the DEA to comprehensively review and incorporate the more than 38,000 comments received on the two companion proposed rules they released in March 2023, detailed below.
The emergency flexibilities will be extended in full until November 11, 2023 (6 months after the end of the PHE). These flexibilities include:
- Patients can be prescribed schedules II-V controlled substances without a prior in-person examination as clinically appropriate and within your normal scope of practice, including through audio-only modalities.
- DEA registration in one state allows prescription of controlled substances in any state.
After November 11, 2023, there is a one-year "off-ramp" that applies to patients that established a treatment relationship via telemedicine and were prescribed a controlled substance(s) during the PHE waivers (from March 2020 up to November 11, 2023). In other words, if the practitioner and patient have established a telemedicine relationship involving the prescription of controlled substances on or before November 11, 2023, the telemedicine flexibilities for the prescribing of controlled substances will apply to them through November 11, 2024. New patients established after November 11, 2023 will not be granted use of those flexibilities.
This means that without the promulgation of additional rules, on November 12, 2023, in-person rules, as well as DEA registration rules, will apply to new patients and on November 12, 2024, in-person and registration rules will apply to established patients. The rules that will apply on these dates will depend on what rules the DEA finalizes, so stay tuned for more information.
DEA and SAMHSA are still reviewing the comments received in March to finalize updated rules regarding telemedicine prescribing of controlled substances after these flexibilities expire. APA submitted comments on March 31st to both the Telemedicine Prescribing of Controlled Substances Proposed Rule and the Expansion of Induction of Buprenorphine via Telemedicine Encounter Proposed Rule.
Please join us at an APA Member Forum at this year’s APA Annual Meeting: Practice & Telepsychiatry After the Public Health Emergency – What You Need to Know on May 22, 2023 in San Francisco. Feel free to drop into APA Office Hours on the end of the PHE this Friday, May 12.
We will share more information as it comes available.
With the end of the COVID-19 public health emergency (PHE) on May 11, 2023, the Ryan Haight Act’s restriction on telehealth prescribing of controlled substances will go back into effect immediately. This means that an in-person visit will be required in order to prescribe controlled substances.
There was an expectation that the Drug Enforcement Agency (DEA) would allow practitioners to register with them in order to prescribe controlled substances without a prior in-person visit on an ongoing basis—referred to as a “special registration.” However, the DEA never issued that special registration, making clinicians anxious about the pathway for maintaining continuity of treatment for their patients after the PHE.
Instead, on Wednesday, March 1, the DEA published two draft, companion rules intended to address the prescribing of controlled substances:
- Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation
- Expansion of Induction of Buprenorphine via Telemedicine Encounter
These rules do not create a “special registration,” but they do provide alternative pathways for psychiatrists providing legitimate access to crucial medications through telemedicine. These are draft rules that DEA hopes to finalize before the end of the PHE on May 11, and comments are due to DEA on March 31, 2023.
Key Takeaways of the Draft Rules Package
- Schedules III-V non-narcotic controlled substances, and buprenorphine for treatment of OUD, would be eligible for a short-term (30-day) supply in advance of an in-person visit.
- Scheduled II-V substances, and buprenorphine for treatment of OUD, would be eligible for a telemedicine prescription if a referral is provided to the prescribing practitioner from another DEA-registered practitioner that has seen the patient in person.
- There would be a six-month “off-ramp” or grace period for patients that established care via telemedicine during the PHE. If the prescription was issued based on a telemedicine visit between March 16, 2020 and May 11, 2023 and the patient hasn’t been seen in person by that prescriber, the in-person requirement wouldn’t kick in until November 7, 2023.
- Practitioners would be required to have a DEA license in the state they are in at the time of the telemedicine visit, not just the state the patient is in.
- There are significant proposed documentation and administrative requirements that go beyond the current requirements for a referral or prescription.
- Lots of questions remain, including how this proposed rule would affect multistate practices and requirements for a physical location in any state in which the practitioner is prescribing.
Share Your Comments and Opinions
APA is submitting comments and clarifications on behalf of our membership and needs your input. Please share how this will affect your patients and your practice with [email protected] or work with your District Branch or other colleagues to submit your own comments. APA members can direct specific questions about your practice to [email protected].
To submit your own comments, click on the link to the draft rule you want to comment on (links are at the top of this post), then click the green "Submit a Formal Comment" button at the top of the page. The comment period closes on March 31, 2023.
- A comprehensive overview of the proposed rule from McDermott, Will & Emery, "DEA Proposes Limited Post-PHE Telemedicine Prescription of Controlled Substances"
- "DEA Proposes Extension of Some Telehealth Prescribing Flexibilities After PHE Ends" from Psychiatric News Alerts
- "If You Are Treating Patients Virtually, Begin Planning Now for End of COVID-19 PHE from Psychiatric News
A Note on Federal vs. State/local Telehealth Policies
- Remember, many of the policies that affect your telepsychiatry practice on a day-to-day basis are based on state, local, or private actions.
- Since the majority of state public health emergencies and associated licensure flexibilities have already ended, you need to be licensed or registered in any state you’re delivering care.
- Commercial and Medicaid coverage of telehealth services vary.
- Keep in touch with your APA District Branch, state medical board, and other trusted advisors to understand policy and practice in your state.