On February 24, 2023, the US Drug Enforcement Administration (DEA) issued two proposed rules (the Telemedicine Controlled Substance Proposed Rule and the Telemedicine Buprenorphine Proposed Rule) that would establish additional potential pathways for the prescription of certain controlled substances in limited quantities via telehealth without an initial in-person medical examination. Currently, this practice is allowed during the COVID-19 public health emergency (PHE), which is slated to end on May 11, 2023. The DEA issued a press release, a chart on practitioner rules, frequently asked questions regarding how the proposed rules may impact practitioners and patients, a flow chart explaining the proposed rules and a handout describing whether a prescription is a controlled substance. Stakeholders have 30 days to comment after publication of the proposed rules in the Federal Register.
Telehealth providers would no longer be able to prescribe Schedule II controlled substances or narcotics without an in-person evaluation.
Telehealth 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 telehealth during the COVID-19 PHE would allow telehealth 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 telehealth provider, by another DEA-registered provider who participates in a real-time audio-visual telehealth 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.
The need for an in-person evaluation would make it more challenging for patients who face significant barriers to accessing care without telehealth to continue receiving the controlled medications they need.
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 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 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 that 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 treatment under special circumstances, although there is no statutory definition) in one of the following seven circumstances:
A. The patient is being treated in and is physically located in a hospital or clinic.
B. The patient is being treated by and in the physical presence of another practitioner.
C. The patient is being treated by a provider employed by the Indian Health Services.
D. 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 and the US Attorney General.
E. The patient is being treated by a practitioner who holds a special registration, requirements for which are set forth at 21 U.S.C. § 831(h).
F. 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).
G. 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 COVID-19 PHE under subparagraph D were set to end with the termination of the PHE on May 11, 2023. Providers and others have long been awaiting 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 act’s passage, the DEA has failed to implement such a process, even though Congress imposed a deadline of October 2019 in the 2018 SUPPORT for Patients and Communities Act for the promulgation of final regulations. In the proposed rules, the DEA opted not to implement the registration process and instead invoked its authority under subparagraph G.
Telemedicine Prescribing of Controlled Substances Without Prior In-Person Evaluation
The Telemedicine Controlled Substance Proposed Rule would amend 21 CFR parts 1300, 1304 and 1305 to establish circumstances under which healthcare practitioners may prescribe certain controlled medications via telemedicine encounters. The proposed rule would only be applicable to telemedicine encounters authorized under 21 U.S.C. § 802(54)(G), and would not be applicable to telemedicine encounters pursuant to 21 U.S.C. §§ 802(54)(A)-(G).
The Telemedicine Controlled Substance Proposed Rule proposes to amend 21 CFR § 1300.04 to modify the definition of the “practice of telemedicine” to require that telemedicine take place “using an interactive telecommunications system referred to in 42 CFR 410.78(a)(3).” This would not be a substantive change to the DEA’s regulations, but merely a clarification of the existing requirements under 42 CFR 410.78(a)(3)—that interactive telecommunications systems include audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site practitioner, and for certain mental health services, real-time audio-only communication technology. The Telemedicine Controlled Substance Proposed Rule also proposes to amend 21 CFR § 1300.04 to add the following definitions:
Finally, the Telemedicine Controlled Substance Proposed Rule proposes a technical amendment to remove from the DEA’s regulations the “[t]emporary definition of the practice of telemedicine” in 21 CFR 1300.04(j).
The Telemedicine Controlled Substance Proposed Rule proposes to amend 21 CFR § 1304.06 to allow practitioners to prescribe non-narcotic Schedule III-V controlled substances when certain circumstances are met. The proposed rule would provide several requirements, to be set forth in 21 CFR §1306.31, that a practitioner must satisfy in order to prescribe a controlled substance via a telemedicine encounter:
The commentary to the Telemedicine Controlled Substance Proposed Rule specifically notes that the third item above would require that a practitioner using telemedicine to prescribe a controlled substance be authorized to prescribe that basic class of controlled substance under DEA registrations in both the state where the practitioner is located and the state where the patient is located.
The Telemedicine Controlled Substance Proposed Rule would allow a practitioner to prescribe non-narcotic Schedule III-V controlled substances, and would exclude the prescription of Schedule II controlled substances via telemedicine encounters. To combat diversion of controlled substances, the Telemedicine Controlled Substance Proposed Rule proposes that prescriptions for controlled substances be time-limited for each patient (unless conducted by VA practitioners). Under the proposed rule, practitioners could prescribe controlled substances to a patient using telemedicine only for a 30-day supply, and could only continue prescribing beyond the 30-day window if the practitioner would have to see the patient in-person, the practitioner performs a synchronous audio-video telemedicine encounter with the patient while the patient is located in the physical presence of another DEA registered practitioner, or the practitioner receives a qualifying telemedicine referral from a DEA registered practitioner who has conducted an in-person exam of the patient. Once any of these criteria is satisfied, the Telemedicine Controlled Substance Proposed Rule would allow a practitioner to continue prescribing a controlled medication to a patient without additional evaluations, unless otherwise required by law.
The Telemedicine Controlled Substance Proposed Rule would require practitioners review the PDMP in the state in which the patient is located for the past year (or for VA practitioners, the VA’s centralized health information system). If the PDMP is nonoperational and therefore a practitioner is unable to review a patient’s prior prescription history, then the practitioner may only prescribe a seven-day prescription of controlled substances, which can only be refilled upon the practitioner s successful review of the PDMP, which must occur within seven days of the telemedicine encounter. During time period in which the practitioner is not able to access the PDMP, she must annotate in the prescription the dates and times she attempted to access the PDMP, the reason why she could not gain access to the PDMP, and any follow-up attempts to gain access to the PDMP. Once able to access the PDMP, the practitioner may refill the prescription for the controlled substance; however, together with the initial seven-day prescription, the refill may not exceed a 30-day supply.
Pursuant to the Telemedicine Controlled Substance Proposed Rule, the DEA proposes to amend 21 CFR § 1304.04 to require practitioners to keep detailed records regarding prescriptions issued as a result of a telemedicine encounter at the registered location identified in the practitioner’s DEA registration (21 CFR § 1301.13.), in digital or paper form that is readily accessible. As part of the practitioner’s records for each prescription a practitioner issues pursuant to a telemedicine encounter, the practitioner must maintain a record of the following:
The Telemedicine Controlled Substance Proposed Rule would also require practitioners to maintain copies of all qualifying referrals they issue. The rule also proposes to set requirements for practitioners to maintain records related to medical evaluations conducted with the patient and another DEA practitioner physically together at the other end of an audio-video link. Both the prescribing practitioner and the DEA-registered healthcare worker physically present with the patient must maintain, for each medical evaluation, the following:
The commentary to the Telemedicine Controlled Substance Proposed Rule acknowledges that practitioners may practice telemedicine in multiple states (e.g., where the patient is located). To avoid the confusion (and the burden) of requiring practitioners to maintain medical records in each state in which they provide telemedicine encounters, and to allow the DEA to readily locate records when necessary, practitioners need only maintain such records at the location identified in their DEA registration (21 CFR § 1301.13).
Expansion of Induction of Buprenorphine via Telemedicine Encounter
The Telemedicine Buprenorphine Proposed Rule would expand the circumstances under which practitioners are authorized to prescribe buprenorphine for use in the maintenance or detoxification treatment of opioid-use disorder via a telemedicine encounter, including an audio-only telemedicine encounter that meets the standard of 42 CFR 410.78(a)(3), provided certain requirements and conditions are met. In addition to the requirements proposed under the Telemedicine Controlled Substance Proposed Rule (the expanded and amended definitions, the record keeping requirements and the prescribing requirements including supply limitations, as outlined above), the Telemedicine Buprenorphine Proposed Rule would amend 21 CFR §1306 to provide the following:
Although the new rules would expand the use of telemedicine for prescribing controlled substances beyond what was allowed before the COVID-19 PHE, they would re-establish the barriers many patients face in accessing in-person care, and the barriers that telehealth providers that do not have physical locations face in providing care, by requiring at least one in-person visit. Even though the DEA did not decide to establish a special registration process, explaining that doing so would be too burdensome for both prospective telemedicine providers and patients, not establishing a telehealth-only pathway to treatment is also burdensome.
What Works
What’s Missing/What Doesn’t Work
State Law Still Matters
Although the Ryan Haight Act is often the focus of telemedicine remote prescribing compliance, in reality remote prescribing regulation is largely left to the states. Remote prescribing restrictions can be commonly found in telemedicine-specific statutes or regulations, pharmacy practice acts and medical practice acts, and in controlled substances acts themselves. Some states may still require an in-person encounter prior to prescribing controlled substances to treat a patient. While many states introduced flexibilities for the prescribing of controlled substances in light of COVID-19, many flexibilities have expired or will expire soon, reverting to the pre-COVID-19 landscape at the state level. As a result, the effect of the DEA’s new position could be limited within a particular state by the application of state laws that are more stringent.
For more information contact: Rachel Stauffer, Amanda Enyeart (McDermott Will & Emery – Partner), Marshall E. Jackson, Jr. (McDermott Will & Emery – Partner), Lisa Mazur (McDermott Will & Emery – Partner), Marika Miller (McDermott Will & Emery – Associate), Grayson I. Dimick (McDermott Will & Emery – Associate), Jayda Greco (McDermott Will & Emery – Associate).
