The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the extension is in place, the DEA indicated that, in light of the 38,000 comments it has received, it will be further evaluating its recently proposed rules for post-PHE telemedicine prescription of controlled substances. Learn what stakeholders need to monitor during this time and what may be next from the DEA.
On May 10, 2023, the DEA and SAMHSA issued a temporary rule extending telemedicine flexibilities adopted during the COVID-19 public health emergency (PHE). The temporary rule will allow telemedicine providers to continue prescribing controlled substances through November 11, 2023, or six months beyond the end of the PHE. The PHE is ending on May 11, 2023, and the temporary rule will go into effect at that time. The DEA and SAMHSA issued this press release along with the announcement.
The restrictions in place before the COVID-19 PHE required a telemedicine provider to perform an in-person medical evaluation of a patient prior to prescribing a controlled substance (with certain limited exceptions). Without the temporary rule extending the telemedicine flexibilities, those restrictions would have gone into effect on May 12, 2023.
While the extension is in place, the DEA indicated that, in light of the 38,000 comments it has received, it will be further evaluating its recently proposed rules for post-PHE telemedicine prescription of controlled substances.
Current flexibilities that allow providers to prescribe certain controlled substances via telemedicine (without an in-person visit) will continue through November 11, 2023.
The temporary rule also provides a one-year grace period for any practitioner-patient “telemedicine relationship established via COVID-19 telemedicine prescribing flexibilities” on or before November 11, 2023. This allows telemedicine providers with established relationships to continue prescribing controlled medications through November 11, 2024.
The DEA is continuing to review the more than 38,000 comments it received on two recently proposed rules (the General Telemedicine Rule and the Buprenorphine Rule). The rules would have established additional potential pathways for the prescription of certain controlled substances in limited quantities via telemedicine without an initial in-person medical examination.
It is unclear if the DEA will revisit an effort to create a special registration process, which it declined to do through the two previously proposed rules and did not address in this temporary rule.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) requires a telemedicine provider to perform an in-person medical evaluation of a patient prior to prescribing a controlled substance to that patient unless an exception applies (21 U.S.C. § 829(e)(1)). The Ryan Haight Act includes a broad exemption to the in-person medical evaluation requirement for the delivery, distribution or dispensing of a controlled substance by a practitioner engaged in the “practice of telemedicine” (21 U.S.C. § 829(e)(3)). However, despite the apparent flexibilities for providers who are delivering services via telemedicine, the “practice of telemedicine” is defined quite narrowly. Specifically, it is defined as an encounter that is provided through a “telecommunications system” (currently defined under 42 CFR § 410.78(a)(3) to require a live audio-visual encounter except with respect to certain mental health treatments under special circumstances, although there is no statutory definition) in one of the following seven circumstances:
The patient is being treated in and is physically located in a hospital or clinic;
The patient is being treated by and in the physical presence of another practitioner;
The patient is being treated by a provider employed by the Indian Health Services;
The treatment is occurring during a PHE declared by the secretary of the US Department of Health and Human Services (HHS) involving locations and controlled substances designated by the Secretary of HHS and the US Attorney General;
The patient is being treated by a practitioner who holds a special registration, requirements for which are set forth in 21 U.S.C. § 831(h);
There is a medical emergency, and the patient is being treated by an employee of the Veterans Health Administration (provided that certain additional requirements are met) or
The patient is being treated under other circumstances as set forth in regulation as determined jointly by the HHS Secretary and the US Attorney General to be consistent with effective controls against diversion and otherwise consistent with the public health and safety (21 U.S.C. § 802(54)).
The controlled substance-prescribing flexibilities invoked in January 2020 in response to the PHE under subparagraph D were set to end with the termination of the PHE on May 11, 2023. Providers and others have long awaited the development of the “special registration” process described in subparagraph E, which would require the DEA to establish the circumstances and procedures under which a special registration could be issued under the Ryan Haight Act. In the 14 years since the Ryan Haight Act’s passage, the DEA has failed to implement such a process, even though Congress imposed an October 2019 deadline in the SUPPORT for Patients and Communities Act for the promulgation of final regulations. In the proposed rules issued in February 2023, the DEA opted not to implement the registration process and instead invoked its authority under subparagraph G.
Under the February proposed rules still under review by the DEA, telemedicine providers would no longer be able to prescribe Schedule II controlled substances or narcotics without an in-person evaluation. Telemedicine providers would be able to prescribe a 30-day supply of Schedule III–V controlled substances or buprenorphine as medication for opioid use disorder without an in-person evaluation, but an in-person evaluation (further explained below) would be required for any renewal of such prescriptions. An exception for provider-patient relationships formed via telemedicine during the PHE would allow telemedicine providers to continue prescribing Schedule II–V controlled medications through November 7, 2023. After that, an in-person evaluation would be required to continue prescribing. An in-person evaluation may be conducted by the prescribing telemedicine provider, by another DEA-registered provider who participates in a real-time audio-visual telemedicine consultation with the patient and the prescribing provider, or by another DEA-registered provider who has performed an in-person evaluation of the patient and refers the patient to the prescribing provider. (See our Special Report: DEA Proposes Limited Post-PHE Telemedicine Prescription of Controlled Substances for more details on the proposed rules.)
The DEA faced significant pushback regarding the pathways provided in the February proposed rules, including from federal lawmakers. This pushback included a record 38,000 comments. Many stakeholders highlighted that the requirement for an in-person evaluation would make it more challenging for patients who face significant barriers to accessing care without telemedicine to continue receiving the controlled medications they need.
In this temporary rule, the DEA acknowledged comments from stakeholders in support of the extension of the PHE telemedicine flexibilities for relationships established both during and following the end of the PHE. The DEA agreed that immediately ceasing the PHE telemedicine flexibilities would jeopardize patient care, including from patient backlogs, as practitioners might be inundated with requests for in-person medical evaluations. The DEA indicated that a six-month extension of the flexibilities, allowing the continuation of practitioner-patient telemedicine relationships established through November 11, 2023, would support patient care while still being an effective control against diversion. The DEA indicated that it did not extend the flexibilities for longer than six months in an effort to disincentivize the creation of telemedicine companies that may seek to engage in problematic prescribing practices.
The DEA recognized that many telemedicine companies are patient-centered prescribing practices operating in good faith. It stated that it looks forward to working with such companies to further enhance patient access to needed medications when telemedicine prescriptions are appropriate and issued in the usual course of professional practice following bona fide medical evaluations.
The DEA plans to issue one or more final rules based on the two February proposed rules before November 11, 2023, possibly extending certain telemedicine flexibilities on a permanent basis. In the absence of final rules, the DEA will need to present a different approach to prescribing controlled substances via telemedicine through a new rulemaking process.