New DEA Rule Extends Controlled Substance Telemedicine Prescribing Flexibilities One More Year

The Drug Enforcement Administration (DEA) just released a new regulation temporarily extending the COVID-era flexibilities for prescribing controlled substances via telemedicine. This third extension continues the “full set” of telemedicine prescribing flexibilities, referencing the two DEA letters that authorized telemedicine waivers, with a new expiration date of December 31, 2025. Practitioners may continue to:

• Prescribe Schedule II-V controlled substances via telemedicine without having conducted an in-person evaluation of the patient, if certain conditions are met (see the DEA’s March 31, 2020 letter).
• Maintain a DEA registration in at least one state (see the DEA’s March 25, 2020 letter).

Without this extension, the telemedicine flexibilities were set to expire at the end of 2024. 

In the new rule, the DEA acknowledged many patients and practitioners have come to depend on telemedicine for prescribing controlled substances. Allowing these flexibilities to expire on December 31, 2024, DEA stated, would disrupt access to care, and potentially harm patients who rely on telemedicine for their medications. The potential reduction in access to care is contrary to the public interest, stated the DEA, particularly if patients are unable to obtain necessary medications.

The DEA limited the extension to one year to avoid incentivizing the creation of new telemedicine companies that might misuse the flexibilities for improper prescribing practices. The one-year extension is intended to give the DEA time to finalize a set of regulations for telemedicine prescribing of controlled substances that will account for feedback from public comments, the Telemedicine Listening Sessions, Tribal Consultations, and meetings held under Executive Order 12866. The DEA plans to issue the final regulations with enough lead time to allow practitioners to come into compliance with any new requirements before the telemedicine prescribing flexibilities expire on December 31, 2025.

略史

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.)

声を届ける

Although stakeholders have secured an extension to the telemedicine prescribing flexibilities, there is still more to do to ensure permanent access to controlled medications. Stakeholders should continue to make their voice heard so the DEA will:

• 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 rule early in 2025 so the rule has adequate time to go through public comment and the administrative rulemaking process before the expiration of the flexibilities.

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

• DEAにメールを送る
• 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

結論

Given how long stakeholders have been waiting for a special registration process, it remains to be seen what the DEA’s proposed rule for 2025 will entail. We will continue to closely monitor the release of this new proposed regulation in the coming year.

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