What You Need To Know: DEA Proposed Rule Regarding Telehealth Prescribing of Controlled Substances with the White House

As of June 2024, a DEA proposed rule regarding telehealth prescribing of controlled substances has reached the White House for review. This review is the final step before the proposal can be released to the public.

Background on the Proposed Rule

At the start of the pandemic in 2020, the Drug Enforcement Administration (DEA) loosened restrictions on remote prescribing of Schedule II-V controlled substances for the duration of the COVID-19 public health emergency. In effect, these changes rolled back specific provisions of the Ryan Haight Online Pharmacy Consumer Protection Act that required a practitioner to establish a provider-patient relationship through an in-person assessment before being able to prescribe controlled medications to that patient. As a result of the 2020 rollback, providers were allowed to prescribe controlled medications through telemedicine without the prior in-person evaluation of the patient. Since these flexibilities were tied to the public health emergency, which was set to expire in May 2023, DEA along with the Department of Health and Human Services (HHS) in March 2023, issued rules to determine the circumstances this flexibility would be continued to be allowed.  The agency received over 38,000 comments from the public on its  rules, the majority of which were in opposition. Subsequently, DEA scrapped those rules and held a listening session in the fall to gather feedback on a special registration process. This process could allow providers to be vetted by the agency before prescribing controlled substances remotely without an in-person visit.

Since the fall, stakeholders have been waiting for DEA to issue a new proposed rule taking into consideration last year’s comments and feedback at the listening session since the waiver of the in-person requirement was extended and set to expire at the end of 2024. On June 13, 2024, that long awaited proposed rule reached the White House’s Office of Management and Budget (OMB), which reviews all significant federal regulations from federal agencies before being released for public input. OMB is supposed to review regulations within 90 days, but this standard is not strictly enforced. There is a possibility that OMB could send it back to the DEA for further revisions. We will closely monitor it and keep you updated with any developments. 

What We Know

While we await the release of the approved rule by the OMB, here’s what we know so far: 

• Once released, stakeholders will have an opportunity to provide comments to the DEA, and the DEA will be required to review that feedback before finalizing the rule.
• There is not currently a separate rule relating to buprenorphine prescribing, indicating that it will not be treated differently than other scheduled drugs like the agency had initially contemplated last year.
• A Special Registration process for telemedicine will be part of the proposed rule, but the devil will be in the details. This Special Registration process could allow providers to be vetted by the agency before prescribing controlled substances remotely without an in-person visit, a measure the industry has broadly supported.
• If the proposed rule creates arbitrary restrictions, stakeholders and the industry will push back forcefully as they have done with previous efforts to regulate the prescribing of controlled substances via telemedicine.
• The proposed rule is rumored to clarify pharmacists’ obligations when dispensing controlled substances, hopefully addressing some of the issues DoseSpot and other advocates have previously raised with the Administration. 
• The White House Office of Management and Budget (OMB) is supposed to review the regulation within 90 days of receiving it before sending it back to DEA, either for further editing or to be published for comment to the public.
• The DEA has publicly committed to not letting the existing telemedicine prescribing flexibilities lapse while the regulatory process for a permanent rule advances and has extended current telemedicine flexibilities through December 31, 2024.

More To Come

Once the rule is published, DoseSpot will host a webinar featuring experts who will analyze its impact and repercussions and suggest actionable next steps for you as practitioners and providers. Please stay tuned for further communications from us on this matter. We hope to provide clarity as the proposal continues to evolve.

Have questions in the meantime? We’re here to help. Reach out to us at sales@dosespot.com.

Sources

“DEA’S PROPOSED TELEMEDICINE REGULATIONS | HIGHLIGHTS FOR MEDICAL PRACTITIONERS”
https://www.dea.gov/sites/default/files/2023-03/Telehealth_Practitioner_Narrative_312023.pdf

DEA Graphic
https://www.dea.gov/sites/default/files/2023-02/Controlled%20Substance%20Guidance.pdf

“DEA and HHS Extend Telemedicine Flexibilities through 2024”
https://www.dea.gov/documents/2023/2023-10/2023-10-06/dea-and-hhs-extend-telemedicine-flexibilities-through-2024

“DEA, SAMHSA Extend COVID-19 Telemedicine Flexibilities for Prescribing Controlled Medications for Six Months While Considering Comments from the Public”
https://www.dea.gov/press-releases/2023/05/09/dea-samhsa-extend-covid-19-telemedicine-flexibilities-prescribing

“DEA Close to Unveiling New Telehealth Regulations for Controlled Substance Prescriptions”
https://bhbusiness.com/2024/06/14/dea-close-to-unveiling-new-telehealth-regulations-for-controlled-substance-prescriptions/