DEA expands telemedicine flexibility for prescribing controlled drugs: Second time’s the charm


On October 6, 2023, the Drug Enforcement Administration (DEA) issued a second temporary rule expanding COVID-19 telemedicine flexibilities for the prescription of controlled drugs. This second extension, issued shortly after DEA’s listening session on potential new telemedicine specialty registrations, gives physicians and patients certainty over DEA requirements for telemedicine prescribing through the end of 2024.

Without this second temporary rule, the COVID-19 telemedicine flexibility will expire on November 11, 2023, with respect to practitioner-patient relationships established after that date (as described in our previous blog post). This second temporary rule – titled “Second Temporary Expansion of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Drugs” – expands DEA’s “full set” of temporary COVID-19 exemptions to prescribe controlled substances via telemedicine. Continues expansion. The relaxations, which are applicable from March 2020, have now been extended 31 December 2024,

Major provisions under the second temporary rule of DEA

1. Which DEA ​​exemptions are extended under this rule?

The DEA said it is again expanding the “full set” of telemedicine flexibilities with respect to prescriptions of controlled drugs, referencing two DEA letters authorizing the telemedicine waiver.

  • The “Dear Registrant” letter dated March 25, 2020 is signed by William T. McDermott, DEA’s then-Assistant Administrator, Diversion Control Division.
  • A “Dear Registrant” letter dated March 31, 2020, signed by Thomas W. Prevoznik, then Deputy Assistant Administrator of the DEA, Diversion Control Division.

The March 25 letter addressed two exemption exceptions: one related to DEA registration in individual states; And an individual assessment is related to the need. It states in relevant part:

  • DEA-registered practitioners are not required to obtain additional registration with DEA ​​in the additional state(s) where dispensing (including prescribing and administering) occurs, for the duration of the public health emergency declared through January 31, 2020. If authorized to distribute a controlled substance by both the state in which a practitioner is registered with the DEA and the state in which the distribution occurs. In other words, practitioners must be registered with the DEA in at least one state and permitted under state law to use controlled substances in the state where the dispensing occurs.
  • Under the Controlled Substances Act (CSA), a prescription for a controlled substance issued via the Internet must generally be based on an individual medical evaluation. See 21 USC § 829(e)(1). However, this requirement does not apply if a practitioner is practicing telemedicine as defined by the CSA. The CSA’s definition of the practice of telemedicine includes several different categories of telemedicine. For many of these categories, the CSA specifically requires a practitioner to have DEA registration in the state in which the patient is located. See, for example, 21 USC § 802(54)(A), (B). But 21 USC § 802(54)(d) does not include this requirement for the practice of telemedicine during a public health emergency. On March 16, 2020, the Secretary of the United States Department of Health and Human Services, with the concurrence of the Acting DEA Administrator, stated that the telemedicine allowance under section 802(54)(d) applies to all Schedule II-V controlled substances. In all areas of the United States.

In the letter dated March 31, the relaxation regarding prescribing of buprenorphine was extended. It states in relevant part:

  • DEA notes physicians have more flexibility during nationwide public health Emergencies to prescribe buprenorphine via telephone by otherwise authorized physicians to new and existing patients with opioid use disorder (OUD), without requiring such physicians to first examine the patient in person or via telemedicine.

On May 11, 2023, Foley received confirmation from the Section Chief of DEA’s Diversion Regulatory Draft and Policy Support Section (Scott Brinks) that the registration policy outlined in the March 25, 2020 letter was being extended. Thus, the PHE policy on single-state DEA registration will continue during the period of flexibility outlined in May 10.th The temporary rule and this second temporary rule have also been expanded.

2. What time period does this second temporary rule cover?

The second temporary rule extends COVID-19 PHE DEA telemedicine flexibilities through December 31, 2024. As stated in the second temporary rule, DEA has removed the distinction between new and previously observed patients outlined in the initial expansion:

  • This extension authorizes all DEA-registered physicians to prescribe Schedule II-V controlled drugs via telemedicine through December 31, 2024, regardless of whether the patient and physician established a telemedicine relationship on or before November 11, 2023 . In other words, the grace period provision provided in the first temporary rule is effectively absorbed into this second temporary rule, which continues to extend the current flexibilities to all practitioner-patient relationships – not just through November 11, 2023. For relationships established on or before – by the end of 2024.

3. Does this rule shed any light on when DEA might issue new proposed regulations on this topic?

Yes. In the second temporary rule, the DEA stated:

  • The DEA is working to implement new standards or safeguards by the end of 2024.

If that estimated timeframe is accurate, and a new proposed rule is issued in late 2024, it won’t be long before this second extension expires. It seems almost certain that a third expansion will be necessary. Only time will tell.

conclusion

This second temporary rule lengthens the runway for telemedicine companies planning to transition by the end of 2024. While both expected and necessary, it remains to be seen what the DEA proposal will look like in 2024 and whether it will include specialized telemedicine registration. stay tuned. We will continue to monitor for updates.

Want to know more?

Foley is here to help you address the short and long-term impacts in the wake of regulatory changes. For more information about telemedicine, telehealth, virtual care, remote patient monitoring, digital health and other health innovations, including team, publications and representative experience, visit Foley’s telemedicine and digital health industry team or our health care practice group,

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