New DEA Rule Extends Managed Substance Telemedicine Prescribing Flexibilities One Extra 12 months

The Drug Enforcement Administration (DEA) simply launched a new regulation briefly extending the COVID-era flexibilities for prescribing managed substances by way of telemedicine. This third extension continues the “full set” of telemedicine prescribing flexibilities, referencing the 2 DEA letters that approved telemedicine waivers, with a brand new expiration date of December 31, 2025. Practitioners could proceed to:

• Prescribe Schedule II-V managed substances by way of telemedicine with out having carried out an in-person analysis of the affected person, if sure situations are met (see the DEA’s March 31, 2020 letter).
• Keep a DEA registration in at the very least one state (see the DEA’s March 25, 2020 letter).

With out this extension, the telemedicine flexibilities have been set to run out on the finish of 2024. 

Within the new rule, the DEA acknowledged many sufferers and practitioners have come to rely on telemedicine for prescribing managed substances. Permitting these flexibilities to run out on December 31, 2024, DEA said, would disrupt entry to care, and doubtlessly hurt sufferers who depend on telemedicine for his or her drugs. The potential discount in entry to care is opposite to the general public curiosity, said the DEA, notably if sufferers are unable to acquire crucial drugs.

The DEA restricted the extension to 1 yr to keep away from incentivizing the creation of latest telemedicine firms that may misuse the flexibilities for improper prescribing practices. The one-year extension is meant to offer the DEA time to finalize a set of rules for telemedicine prescribing of managed substances that may account for suggestions from public feedback, the Telemedicine Listening Periods, Tribal Consultations, and conferences held underneath Govt Order 12866. The DEA plans to difficulty the ultimate rules with sufficient lead time to permit practitioners to return into compliance with any new necessities earlier than the telemedicine prescribing flexibilities expire on December 31, 2025.

A Temporary Historical past

The principles stem from the Ryan Haight Act, which amended the Managed Substances Act to limit clinicians from prescribing managed substances until the clinician conducts an in-person examination of the affected person. The Managed Substances Act additionally requires clinicians acquire a separate DEA registration in every state the place their sufferers are situated. Congress anticipated the DEA to difficulty the particular registration rule shortly after the Ryan Haight Act was signed into regulation in 2008. After years of DEA failing to take action, Congress and the White Home signed the SUPPORT Act of 2018, a federal regulation that mandated DEA promulgate the particular registration rule by October 2019. 5 years later, DEA has but to launch the rule.

Throughout the COVID-19 Public Well being Emergency (PHE), the DEA enacted sure flexibilities permitting clinicians to prescribe managed substances with out an in-person examination and with a DEA registration in only one state. In February 2023, two months earlier than the top of the PHE, the DEA proposed a rule on telemedicine prescribing of managed substances, however the rule was not favorably-viewed. The DEA acquired super criticism from personal trade and public officers with the proposed rule netting a record-breaking 38,000 public feedback, practically all of which have been scathingly important of the rule and the way it failed to acknowledge how medical companies are literally delivered by clinicians and pharmacies. Following the general public backlash, the DEA shortly rescinded the proposed rule and prolonged the COVID-era flexibilities (as soon as in Could 2023 and once more in October 2023). The 2 extensions have been supposed to offer extra time for the DEA to draft a workable rule on a particular registration for telemedicine prescribing of managed substances. (For extra particulars, see our earlier discussions on the DEA’s proposed guidelines for telemedicine prescribing of managed substances and first and second short-term guidelines extending COVID-era flexibilities.)

Make Your Voice Heard

Though stakeholders have secured an extension to the telemedicine prescribing flexibilities, there’s nonetheless extra to do to make sure everlasting entry to managed drugs. Stakeholders ought to proceed to make their voice heard so the DEA will:

• Create a private-public taskforce composed of stakeholders and working towards clinicians who prescribe by way of telemedicine to offer important suggestions to the DEA so it’s higher geared up to draft a brand new proposed rule establishing the particular registration course of.
• Publish the brand new proposed rule early in 2025 so the rule has enough time to undergo public remark and the executive rulemaking course of earlier than the expiration of the flexibilities.

Individuals who care about this difficulty can share their considerations by way of the next channels:

• Electronic mail the DEA
• Ship a letter or e-mail to:
  • Senator Mark Warner’s workplace
  • US Consultant Buddy Carter’s workplace
  • Senator Doris Matsui’s workplace
  • Your native Congressperson
• Ship a letter or e-mail to the White Home

Conclusion

Given how lengthy stakeholders have been ready for a particular registration course of, it stays to be seen what the DEA’s proposed rule for 2025 will entail. We are going to proceed to intently monitor the discharge of this new proposed regulation within the coming yr.

For extra data on telemedicine, telehealth, digital care, distant affected person monitoring, digital well being, and different well being improvements, together with the crew, publications, and consultant expertise, go to Foley’s Telemedicine & Digital Well being Trade Group.