Foley & Lardner Comment Letter on DEA Telemedicine Controlled Substance Proposed Rule

On March 1, 2023, the Drug Enforcement Agency (DEA) officially published proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency expires. The DEA gave the public a 30 day window to submit comments, after which it will issue final regulations.

On February 27, 2023, attorneys from Foley & Lardner’s Telemedicine & Digital Health Industry Team reviewed the advance copy of the proposed rule and published a legal guidebook for practitioners, policymakers, and telemedicine companies on what the proposed rules actually would do. Later that week, at the American Telemedicine Association (ATA) Annual Meeting, hundreds of stakeholders met to discuss the proposed rule.

The response from patients, clinicians, policymakers, and industry thought leaders was swift and loud, with more than 20,000 comments submitted on the proposed rule (a “tsunami of criticism”). Leading professional associations, respected think tanks, and experienced clinicians submitted compelling and noteworthy comment letters explaining how the proposed rule will result in limitations on access to care, harm patients in rural and urban areas alike, and likely result in otherwise avoidable overdoses and deaths when patients are denied access to their medically-important medications. (As examples, see comments from ATA and ATA Action here and here, comments from Brookings here, and a New York Times opinion piece here.)

Attorneys from Foley & Lardner’s Telemedicine & Digital Health Industry Team prepared a comment letter for submission as well. Read a copy of the comments here.

Make Your Voice Heard: How to Submit Comments to the DEA

DEA is soliciting comments until 11:59 p.m. on March 31, 2023. Anyone may submit comments – anonymously or otherwise – via electronic submission at this link. When commenting, refer to “Docket No. DEA-407” on all correspondence, including attachments. Alternatively, commenters may submit comments by mail to:

Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, VA 22152.

Conclusion

The DEA proposed a complex rule with many technical features that will deeply affect a cohort of patients whose clinical care is dependent upon their medications. The DEA gave the public only 30 days to comment on the proposals, after which DEA will prepare final regulations. Providers, facilities, technology companies, professional associations, and patients themselves must consider submitting comments to make your voices heard.

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.

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