November 28, 2023

Digital Divides – An Update on DEA Rules for Remote Prescribing of Controlled Substances

Tym Rourke

Tym Rourke

Background

Earlier this year, Third Horizon Strategies (THS) published an overview of the Drug Enforcement Agency (DEA) proposed rules regarding the remote prescribing of controlled substances via telehealth. These proposed rules were in response to the conclusion of the COVID-19 Public Health Emergency. At the time, advocates, providers and patients raised concerns that the requirements around in-person visits, additional administrative burdens, and changes to prescribing processes would hinder access to care for patients who rely on telehealth for prescribing for both primary and behavioral health conditions. After receiving over 38,000 comments on the proposed rules, the DEA and the Substance Abuse and Mental Health Services Administration (SAMHSA) extended the COVID-era policies around telehealth prescribing through November 11, 2024. Earlier this month, the DEA and SAMHSA extended the policies through December 31, 2024.

 

What the Extension Means

This extension aims to ensure no interruptions in care, stability in practice for patients and providers, and more time for federal officials to review submitted comments to the proposed rules and engage in additional stakeholder conversations. In September, the DEA hosted telemedicine listening sessions with advocates and industry leaders. The listening sessions are publicly available for viewing on the DEA YouTube channel

The DEA continues to consider feedback from these events, with groups like the American Telemedicine Association (ATA) and ATA Action advocating on the best ways forward for rulemaking and regulations to ensure equitable access to care.

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What Happens Next

Though the COVID-era allowances for remote prescribing without an in-person visit will remain in place for more than a year, it is anticipated that federal officials will need to post final rules and regulations well in advance of the extension end date. Further regulatory guidance will likely be developed in mid-2024, which will launch a period of adjustment, where providers and patients may need to alter their care plans and practices to comply with any new regulations that may take effect on January 1, 2025.

In addition to paying close attention to DEA and SAMHSA’s announcements related to these issues in 2024, providers should continue carefully monitoring local and state policies related to remote prescribing. For example, in September, the North Carolina Board of Medicine published an amendment to its Telemedicine Position Statement, articulating its view that telemedicine for remote prescribing should first require an in-person visit. Though the position statement is considered guidance and not codified in regulation, it could impact providers’ willingness to offer telehealth-only primary or behavioral health prescribing where controlled substances are utilized. While DEA final rules will hopefully clarify lines of regulatory authority between the federal government and states and clarify practice guidelines, providers should be mindful to ensure their current practice complies with both COVID-era extended rules while adhering to any state-level regulations that may remain more restrictive.

 

The Future of Remote Prescribing

Ongoing public conversations and communications signal that the final rules DEA will publish in 2024 will look dramatically different than the proposed rules considered in early 2023. In addition to alleviating the potential burdens of in-person requirements, there remains hope from advocates that the DEA may revitalize a congressionally mandated effort to develop a Special Registry that would alleviate significant administrative burdens and allow providers to continue to engage in remote prescribing without risk to care continuity and ease. THS will continue to monitor this issue with the firm’s clients and partners and stand ready to support providers, systems, and patients who rely on digital health solutions to improve equitable and easy access to care.

Senior Director Tym Rourke is a health philanthropy and policy professional with over 15 years’ experience in substance use and mental health disorder prevention and treatment, coalition building, policy and advocacy, and civic engagement. Tym previously served as a Director at the New Hampshire Charitable Foundation and as the chair of the New Hampshire Governor’s Commission on Substance Use. He has extensive experience advising individual and institutional donors, community stakeholders, entrepreneurs and leaders at the local, state, and national level on best practices in behavioral health, and transforming health care systems to improve access and quality.