The Drug Enforcement Agency (DEA) issued a new regulation on May 10, 2023, entitled “Temporary Extension of COVID-19 Telemedicine Flexibility for Prescription of Controlled Medications”. This temporary extension applies to the full set of DEA COVID-19 waivers for telemedicine prescribing of controlled substances. These waivers, in effect since March 2020, have now been extended through November 11, 2023. Additionally, the waivers will continue to apply through November 11, 2024, for any practitioner-patient relationships created during the waiver period.
According to a copy of the rule posted May 9, providers can prescribe controlled substances such as Adderall online through Nov. 11, 2023. Providers who have established a relationship with a patient before that date may also prescribe controlled substances for up to an additional year.
While this is only a temporary extension of the COVID era prescribing flexibility, it is important for patients and clinicians who primarily use telemedicine for healthcare. The public made their choices known through submission of nearly 40,000 comments to the proposed telemedicine rule. The DEA and Substance Abuse and Mental Health Services Administration (SAMHSA) leadership heeded these public comments, prompting this extension. The American Telemedicine Association (ATA) also played a part with their advocacy programs that work to provide patients access to improved care.
DEA’s Temporary Rule Provisions
The Ryan Haight Act is based on the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, that prohibits the distribution, dispensing, or delivery of controlled substances without a valid prescription. This rule limits the circumstances under which a practitioner can prescribe a controlled substance over the Internet without first conducting an in-person medical examination. The DEA Administrator and the Secretary of Health and Human Services have jointly determined that this ruling is consistent with effective controls against diversion and in support of public safety and health.
As part of the act, practitioners are required to assess patients in-person at least one time before prescribing controlled substances online or via telemedicine. There is no expiration period or requirement for an additional annual exam after the practitioner completes this in-person medical evaluation. Civil and criminal penalties may result if the evaluation is not performed and constitutes a per se violation of the Controlled Substances Act (CSA).
The Ryan Haight Act prohibits online pharmacies from selling controlled substances without a valid doctor-patient relationship and applies to all practitioners who prescribe controlled substances over the Internet. This Act works to decrease incidents of illegal prescribing and drug diversion and has also allowed the DEA to regulate the marketplace and to sanction practitioners and pharmacies who violate the law.
The Ryan Haight Act does provide some noted exceptions to the in-person medical evaluation requirement for telemedicine practice.
What is the intended effect of the extension?
This ruling is designed to support continuity of care and prevent treatment lapses under the COVID-Public Health Emergency (PHE) telehealth flexibilities. Moreover, it reinforces the telemedicine relationships established during the COVID-19 PHE and addresses the urgent public health need for continued access to buprenorphine for the treatment of opioid use disorders. The extension provides patients, practitioners, pharmacists, and ancillary providers time to prepare for future regulation changes regarding telemedicine prescriptions. Additionally, it offers the government time to evaluate regulatory alternatives that support the continued expansion of balanced telemedicine care while reducing dishonest prescribing patterns and diversion.
Time period coverage
COVID-19 PHE telemedicine flexibilities will be extended through November 11, 2024, for any practitioner-patient relationships established via telemedicine prior to that date. All telemedicine flexibilities regarding controlled medication prescriptions will also remain in effect until November 11, 2023. A grace period of one year until November 11, 2024, extends all telemedicine flexibility regarding the prescription of controlled medications that were in place during the COVID-19 PHE for practitioner-patient relationships established before November 11, 2023.
Which DEA waivers are affected?
Two DEA letters extend the full set of telemedicine waivers for online prescribing, a March 25, 2020, letter, “Dear Registrant” signed by William T. McDermott, DEA’s then-Assistant Administrator, Diversion Control Division, and a March 31, 2020 “Dear Registrant” letter signed by Thomas W. Prevoznik, DEA’s then-Deputy Assistant Administrator, Diversion Control Division. These letters address two waiver exceptions relating to the issues of registration in individual states, and in person evaluation requirements.
DEA-registered practitioners are not required to obtain additional DEA registrations in the states where the prescribing and dispensing occurs for the duration of the public health emergency declared on January 31, 2020. Practitioners may dispense controlled substances if both the state of their DEA registration and the state of dispensing authorizes them to do so. The practitioner must be registered with DEA in at least one state and have permission to dispense controlled substances in the state where dispensed.
The DEA strongly supports policies, including telehealth prescribing of buprenorphine that ensure access to safe treatment for opioid use disorder. Buprenorphine prescribing waivers were extended in the March 31 letter. It stated that authorized practitioners have further flexibility during the nationwide public health emergency to prescribe buprenorphine to new and existing patients with opioid use disorder (OUD) via telephone or telemedicine without first conducting an examination of the patient in person.
Allow prescriptions for controlled substances issued online must generally be accompanied by an in-person medical evaluation under the Controlled Substances Act (CSA), Practitioners practicing telemedicine as defined by the CSA are exempt from this requirement. Multiple types of telemedicine are defined by the CSA as part of the practice of telemedicine. In several of these categories, the CSA specifically requires practitioners to be registered with the DEA in the state where the patient resides. Telemedicine during a public health emergency is exempt from this requirement under 21 U.S.C. 802(54)(D). As of March 16, 2020, the Secretary of Health and Human Services and the DEA designated all schedule II-V controlled substances in all areas of the United States to be covered by the telemedicine allowance under section 802(54)(D).
Telemedicine relationships established under COVID-19 telemedicine prescribing flexibilities is defined as a patient/physician relationship where a practitioner has not conducted an in-person medical exam. This remains in effect during the period May 12, 2023, through November 11, 2023, if the practitioner prescribed one or more controlled substances to the patient and with certain conditions. A practitioner must issue the prescription for a legitimate medical purpose, and in the context of an interactive telecommunications system as described in 42 C.F.R. § 410.78(a)(3). The physician must also be authorized under their registration under 21 C.F.R. § 1301.13(e)(1)(iv) to prescribe the basic class of controlled substance specified on the prescription or be exempt from registration to dispense controlled substances under 21 U.S.C. § 822(d). Lastly, the prescription must be consistent with all other requirements of 21 C.F.R. Part 1306. The policy of single-state DEA registrations will continue for the duration of the temporary rule’s flexibilities.
The DEA continues to be concerned about problematic prescription practices and is actively investigating telemedicine companies that engage in erroneous prescribing. These problematic online telemedicine companies will be engaged by the DEA to provide proper patient access to medications when telemedicine prescriptions are appropriate and issued via appropriate medical evaluations by licensed providers.
Moving forward
The purpose of this temporary rule, according to DEA, is to ensure a smooth transition for patients and practitioners who rely on telemedicine for controlled medication prescriptions, and to provide adequate time for providers to comply with any new standards or safeguards that DEA or SAMHSA may adopt in a final rule.
According to DEA, it plans to issue one or more final rules based on the two proposed rules published on March 1, 2023. This final rule could extend certain telemedicine flexibilities permanently to allow the practice of telemedicine under conditions that are consistent with public health and safety, while maintaining effective controls against diversion.
If your providers have questions or concerns outlining the DEA’s extension of telemedicine prescribing rule, please contact us 412.424.2260 or email us at info@vowhs.com. For more information regarding our telehealth services, please click virtual medicine solution.
