New DEA Rule Expected to Extend Controlled Substance Telemedicine Prescribing Flexibilities Through 2025

After considerable pressure from both Congress and the White House, the Drug Enforcement Administration (DEA) submitted a proposed rule regarding flexibilities on telemedicine prescribing of controlled substances on October 11, 2024. Specifics of the proposed rule are not yet available, but we anticipate the rule will extend the current DEA telemedicine prescribing flexibilities for at least one more year, possibly two. The proposed rule is expected to be released and available for public review before the end of the year and should extend both the in-person exam waiver and the state-by-state DEA registration waiver.

In late August 2024, POLITICO broke news on the DEA’s internal plans to release an unworkable regulation that would render telemedicine prescribing of controlled substances functionally impractical. Although the draft rule was not publicly released, reporters uncovered how the U.S. Department of Health and Human Services strongly opposed the DEA’s draft, having formally objected to its release at least three times and lodging approximately 400 line-item concerns regarding it. After the news broke, stakeholders were stunned and disappointed. Soon after, patients, clinicians, and leading advocacy associations such as the American Telemedicine Association, ATA Action, and the Alliance for Connected Care, took action through online petitions, and a series of scathing letters from Senators and other members of Congress urged the DEA to honor its prior promises to issue a set of telemedicine regulations before the end of 2024.

Now, with insufficient time before the end of the year to enact a special registration rule, the only path forward to avoid the Telehealth Cliff is to extend the flexibilities further. This will allow time for the DEA to draft a new proposed rule (ideally doing so in collaboration with a taskforce comprised of practicing clinicians and industry stakeholders). Without an extension, the flexibilities that have increased access to health care for individuals in rural and underserved communities over the past four years will disappear after December 31, 2024, resulting in thousands of patients facing the Telehealth Cliff and losing access to critical medications.

A Brief History

The rules stem from the Ryan Haight Act, which amended the Controlled Substances Act to restrict clinicians from prescribing controlled substances unless the clinician conducts an in-person exam of the patient. The Controlled Substances Act also requires clinicians obtain a separate DEA registration in each state where their patients are located. Congress expected the DEA to issue the special registration rule shortly after the Ryan Haight Act was signed into law in 2008. After years of DEA failing to do so, Congress and the White House signed the SUPPORT Act of 2018, a federal law that mandated DEA promulgate the special registration rule by October 2019. Five years later, DEA has yet to release the rule.

During the COVID-19 Public Health Emergency (PHE), the DEA enacted certain flexibilities allowing clinicians to prescribe controlled substances without an in-person exam and with a DEA registration in just one state. In February 2023, two months before the end of the PHE, the DEA proposed a rule on telemedicine prescribing of controlled substances, but the rule was not favorably-viewed. The DEA received tremendous criticism from private industry and public officials with the proposed rule netting a record-breaking 38,000 public comments, nearly all of which were scathingly critical of the rule and how it failed to recognize how medical services are actually delivered by clinicians and pharmacies. Following the public backlash, the DEA quickly rescinded the proposed rule and extended the COVID-era flexibilities (once in May 2023 and again in October 2023). The two extensions were intended to provide additional time for the DEA to draft a workable rule on a special registration for telemedicine prescribing of controlled substances. (For more details, see our previous discussions on the DEA’s proposed rules for telemedicine prescribing of controlled substances and first and second temporary rules extending COVID-era flexibilities.)

What Happens if the Flexibilities Expire?

If the flexibilities expire, clinicians planning to prescribe controlled substances via telemedicine must:

Meet one of the seven (narrow) exceptions under the Ryan Haight Act or conduct an in-person exam of the patient; and
Obtain a separate DEA registration in every state in which their patients are located.

These requirements must be met even if the clinician has been treating the patient since 2020 under the COVID-era flexibilities because DEA has stated there is no “grandfathering” provision under the law that would allow clinicians to continue to prescribe for these patients after the flexibilities expire. The stakes are high for clinicians, as failure to comply with these requirements constitutes a per se violation of the Controlled Substances Act and may lead to criminal or civil penalties and revocation or suspension of the clinician’s DEA registration. Any adverse action taken against the clinician’s DEA registration would trigger disclosures to state professional licensing boards, Medicare, Medicaid, and likely the clinician’s employer.

Make Your Voice Heard

Although there is no published rule to comment on yet, in order to maintain patients’ ongoing access to controlled medications, stakeholders should continue to make their voice heard so the DEA will:

Extend the telemedicine prescribing flexibilities for two more years.
Create a private-public taskforce composed of stakeholders and practicing clinicians who prescribe via telemedicine to provide essential feedback to the DEA so it is better equipped to draft a new proposed rule establishing the special registration process.
Publish the new proposed special registration rule early in 2025 so the rule has adequate time to go through the administrative rulemaking process before the expiration of the flexibilities.

People who care about this issue can share their concerns via the following channels:

Email the DEA
Send a letter or email to:
- Senator Mark Warner‘s office
- US Representative Buddy Carter’s office
- Senator Doris Matsui‘s office
- Your local Congressperson
Sign the online petition for Women’s Health access urging the DEA to extend the telemedicine prescribing flexibilities
Sign the ATA Action online petition calling on Congress and the Biden Administration to support extending the telemedicine prescribing flexibilities

Conclusion

We will continue to monitor the rule development and provide updates.

For more information on telemedicine, telehealth, virtual care, remote patient monitoring, digital health, and other health innovations, including the team, publications, and representative experience, visit Foley’s Telemedicine & Digital Health Industry Team.

Disclaimer

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.