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DEA Proposes New Telehealth Prescribing Rules

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By sHAnnon Britton HArtsFielD AnD nili yolin

The COVID-19 public health emergency (PHE) is set to expire on May 11, 2023, and there seems to be a scramble to extend some of the pandemic-related flexibilities involving telehealth. The U.S. Drug Enforcement Administration (DEA) recently released two notices of proposed rulemaking to allow some of those flexibilities to continue, but the proposed rules are nevertheless more restrictive than what has been permitted since the PHE went into effect. One proposed rule will no longer permit telehealth providers to prescribe controlled substances if the patient never had an in-person examination, subject to limited exceptions. Another proposed rule would expand the situations where doctors may prescribe buprenorphine, used in pain and withdrawal management.

Telehealth Prescribing of Controlled Substances

Pursuant to the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Act), which serves as the basis for the proposed rules, unless one of seven exceptions applies, controlled substances may not be distributed online without a valid prescription. Additionally, a provider must conduct at least one in-person patient visit before prescribing a controlled substance over the internet. The failure to conduct an in-person examination constitutes a violation of the Controlled Substances Act and carries potential civil and criminal penalties. When the PHE went into effect in 2020, the DEA suspended the in-person exam requirement and allowed pro- viders to prescribe controlled substances via telehealth as long as the prescription was for legitimate medical purposes and the prescribing practitioner was acting in accordance with applicable federal and state laws.

Under the proposed rule, Schedule II controlled substances such as Ritalin, Adderall and Vicodin and Schedule III-V narcotics other than buprenorphine may not be prescribed to patients without an in-person evaluation. Providers would be able to prescribe a 30-day supply for buprenorphine and non-narcotic Schedule

III-V drugs such as Xanax and Ambien without an in-person visit if the telemedicine encounter is for a legitimate medical purpose. Anything beyond a 30-day supply will require an in-person visit. If a patient had already been receiving prescriptions by telemedicine during the PHE, the DEA will defer the in-person exam requirement for an additional 180 days.

Prescribing Buprenorphine for Opioid Use Disorder

Balancing the safety measures imposed by the Act with the need to expand access to certain narcotics, the DEA wants to expand access to buprenorphine due to the substantial increase in fatal drug poisonings involving illegal synthetic drugs. The proposed rule would allow authorized providers to prescribe buprenorphine for use in the treatment of opioid use disorder (OUD) via telemedicine, including through an encounter that is audio-only. According to the DEA, the amount of fentanyl seized in 2022 is enough “to supply a potentially lethal dose to every member of the U.S. population.” The proposed rule would

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