In light of the COVID-19 pandemic, the Drug Enforcement Agency (“DEA”) recently issued guidance permitting the use of telemedicine to prescribe controlled substances (schedule II to V) for the duration of the public health emergency declared by the Secretary of Health and Human Services.
Specifically, if (a) the prescription “is issued for a legitimate medical purpose” in the usual course of professional practice; (b) “audio-video, real-time, two-way interactive communication system” is used for the telemedicine encounter; and (c) the practitioner complies with applicable state and federal laws, then controlled substances may be prescribed via telemedicine without first conducting an in-person medical evaluation. DEA FAQ. Nonetheless, if the practitioner has previously conducted an in-person examination, then telemedicine may be used to prescribe controlled substances regardless of whether a public health emergency has been declared as long as the prescription is made in compliance with state law and within the usual course of the provider’s professional practice. Id.
It is important to reiterate that DEA’s liberalization of regulations governing prescription of controlled substances issued using telemedicine is effective only during the COVID-19 public health emergency. However, we expect more permanent DEA action in the coming months. In October 2018, President Trump signed the Special Registration for Telemedicine Act of 2018, which gave the DEA one year to create a special registration that would allow the prescription of controlled substances via telemedicine. Congress intended this new DEA registration to explicitly permit certain providers to prescribe controlled substances via modern telemedicine modalities (e.g., direct patient encounters via video conference). Yet to date the Department of Justice has failed to issue implementing regulations. This crisis may spur permanent rulemaking.
Background of e-prescribing of controlled substances
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“Ryan Haight Act”) prohibits the prescription of controlled substances via the Internet (1) unless the practitioner has conducted a prior in-person medical evaluation of the patient or (2) except pursuant to a qualified “telemedicine” encounter. The definition of a qualified telemedicine encounter is narrow, and generally applies only to telemedicine encounters where the patient is in the physical practice of another practitioner or physically located in a hospital or clinic. When Congress initially passed the bill in 2008, it gave DEA authority to create a special telemedicine registration for additional telemedicine modalities. More than a decade after the Ryan Haight Act’s initial passage, DEA had not done so.
That was supposed to change in late 2019. The Special Registration for Telemedicine Act of 2018 required the DEA to exercise its dormant authority and create such a special telemedicine registration. The DEA’s rulemaking authority dictates that the telemedicine registrant must (a) demonstrate a legitimate need for the telemedicine registration, (b) be registered to deliver or dispense controlled substances under state law (of the state where the patient is located), and (c) comply with other applicable state law. Though the law does not give the DEA any guidelines for what qualifies as “legitimate need,” DEA could use this authority to create a broader definition of “telemedicine” encounter, one that will facilitate prescribing of controlled substances via modern telemedicine modalities and without an in-person exam.
The 2018 act required the DEA to publish the rule by October 24, 2019. However, to date it has not done so. On January 20, 2019, Senator Mark Warner of Virginia sent a letter to Uttam Dhillon, Acting Administrator of the DEA, highlighting the missed deadline. However, to date no action has been taken.
States take varied approaches to the use of telemedicine
Notably, any recipient of this new DEA telemedicine registration must still comply with state laws governing a practitioner’s prescriptive authority. Fortunately, there has been a substantial activity at the state level to clarify whether and in what contexts providers may prescribe controlled substances via telemedicine.
Several states allow providers to prescribe controlled substances via telemedicine, but only to treat specific conditions. Connecticut’s e-prescribing law, passed in July 2018, allows a telehealth provider to prescribe schedule II or III controlled substances (other than an opioid drug) for the treatment of a person with a psychiatric disability or substance use disorder. Conn. Gen. Stat. § 19a-906. Similarly, Florida bans providers from prescribing controlled substances through telemedicine except for the treatment of psychiatric disorders, inpatient treatment at an appropriately licensed hospital, the treatment of patient receiving hospice services, and the treatment of a resident of a nursing home facility. Fla. Stat. § 456.47(c).
In New Jersey, telehealth prescriptions of schedule II controlled substances are permitted as long as an initial in-person examination of the patient takes place, and subsequent in-person visits with the patient take place every three months “for the duration of time that the patient is being prescribed” the schedule II controlled substance. N.J. Stat. § 45:1-62(e). However, for minor patients being prescribed a stimulant that is a schedule II controlled substance, in-person examination and subsequent review may not be required as long as a written waiver of these requirements from the minor patient’s parent or guardian is obtained, and interactive, real-time, two-way audio and video technology is used to treat the minor patient. Id.
Similarly, Louisiana requires that a physician prescribing controlled substances via telemedicine must have had at least one in-person visit with the patient within the past year, but this requirement is not applicable to a physician “who holds an unrestricted license to practice medicine” in Louisiana and practices in a state licensed facility registered with the DEA. La. Admin. Code tit. 46:XLV, § 7513. Additionally, Louisiana requires that the prescription (a) must be for a legitimate purpose, (b) conforms with the standard of care applicable to in-person visits, and (c) complies with applicable state and federal laws. Id.
Indiana allows for the e-prescription of controlled substances for a wider array of conditions, but requires that the controlled substance be prescribed pursuant to a treatment plan created by a provider who has had an in-person encounter with the patient. Ind. Code § 25-1-9.5-8. The State of Washington, Medical Quality Assurance Commission has issued a guideline for the appropriate use of telemedicine, which states that “[w]here appropriate clinical procedures and considerations are applied and documented, practitioners may exercise their judgment and prescribe medications as part of Telemedicine. Especially careful consideration should apply before prescribing DEA-controlled substances . . . .” Appropriate Use of Telemedicine, MD2014-03.
Oregon issued a specific medical license that enables out-of-state physicians to practice medicine in Oregon across state lines (i.e., via telemedicine). Oregon specifically prohibits the holder of a telemedicine license from acting as a dispensing physician, and the applicable regulations prohibit such licensees from “writing prescriptions for medication resulting only from a sale or consultation over the Internet.” OAR 847-025-0000(1)(d).
Idaho permits prescription of controlled substances using telehealth as long as the prescription was made in compliance with applicable federal laws, such as 21 U.S.C. § 802(54)(A). Idaho Code § 54-5707(1). Also, in Delaware, subject to limitations set by the Board of Medical Licensure and Discipline, “[p]rescriptions made through telemedicine and under a physician-patient relationship may include controlled substances.” 24 Del. C. § 1769D(g).
We expect state legislatures and medical boards to continue to expand the ability of practitioners to prescribe controlled substances via telemedicine modalities. Unfortunately, practitioners have had to wait longer than Congress intended for the DEA to implement its own more permissive rules.
 Additional narrow exceptions apply to the Indian Health Services, validly declared public health emergencies, and emergency situations involving the Department of Veterans Affairs.