On March 17, 2020, U.S. Department of Justice, Drug Enforcement Agency (DEA) released guidance clarifying that restrictions under the Ryan Haight Act (the Act) are removed in response to the COVID-19 pandemic, allowing health care practitioners to prescribe controlled substances to patients through the use of telemedicine without any “in-person medical evaluation.” The Act generally prohibits practitioners from dispensing controlled substances through the internet without an in-person evaluation, unless an applicable exception is met. One exception to the Act occurs in the event of a public health emergency, which was triggered when HHS Secretary Alex Azar declared an emergency in response to COIVD-19 effective January 31, 2020. Practitioners now have the go-ahead to prescribe controlled substances through telemedicine technology without compliance with the Act’s requirements, but only for the duration of the public health emergency due to COVID-19.
Texas followed suit yesterday when the Governor granted the Texas Medical Board’s request for a waiver of a Texas regulation that prohibited the treatment of chronic pain with scheduled drugs through use of telemedicine medical services. Now physicians may issue refills of valid prescriptions to established chronic pain patients for treatment of chronic pain via telemedicine.
DEA Announcement Regarding COVID-19
The DEA announced on March 17, 2020 via its website that healthcare professionals may now prescribe controlled substances without meeting the requirements of the Ryan Haight Act. The Act generally prohibits practitioners from online prescribing and dispensing of controlled substances without an in-person evaluation, unless an applicable exception is met. The Act is discussed in more detail below.
One exception to the in-person medical evaluation requirement under the Act occurs when the Secretary of Health and Human Services has declared a public health emergency. That exception was triggered when HHS Secretary Alex Azar declared a public health emergency with regard to COVID-19 effective January 31, 2020. The DEA cited to the Ryan Haight Act’s “public health emergency” exception in its justification of the waiver of restrictions.
The DEA confirmed that, for as long as the public health emergency designation remains in effect, DEA-registered practitioners may issue prescriptions for controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided all of the following conditions are met:
- The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice;
- The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system; and
- The practitioner is acting in accordance with applicable Federal and State law.
Provided the practitioner satisfies the above requirements, the practitioner may issue the prescription using any method of prescribing currently available per DEA regulations. Thus, the practitioner may issue a prescription electronically (for schedules II-V).
Texas Waiver for Chronic Pain Patients
States have begun to respond to the DEA announcement, issuing their own waivers. Texas is a recent example. On March 19th, Governor Abbott approved the Texas Medical Board’s request to temporarily suspend Title 22, Chapter 174.5 (e)(2)(A) of the Texas Administrative Code, which governs the issuance of prescriptions and prohibits the treatment of chronic pain with scheduled drugs through use of telemedicine medical services. Due to the need to ensure there is proper oversight of chronic pain management, this suspension is only in effect until April 10, 2020.
This state waiver allows telephone refill(s) of a valid prescription for treatment of chronic pain by a physician with an established chronic pain patient. The physician(s) remains responsible for meeting the standard of care and all other laws and rules related to the practice of medicine. The standard of care must still be maintained related to the treatment of chronic pain patients.
Background on the Ryan Haight Act
The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 was enacted with the intention of combatting illegitimate online or internet pharmacies selling controlled substances to the public. The Act amended the federal Controlled Substances Act to prohibit the delivery, distribution, or dispensing of a controlled substance by means of the internet without a valid prescription. Generally, for a prescription to be deemed a “valid prescription” under the Act, the online prescription must be issued by an appropriately licensed medical practitioner, and only after the practitioner has conducted at least one in-person medical evaluation of the patient.
Yet, a practitioner engaged in the “practice of telemedicine” is exempt from the in-person medical evaluation requirement. The Act defines the “practice of telemedicine” narrowly. Therefore, a practitioner may prescribe controlled substances in compliance with the Act by 1) satisfying the in-person medical evaluation requirement, or 2) in the absence of an in-person medical evaluation, ensuring that their conduct qualifies as the practice of telemedicine, meaning that they meet a below exception.
The Ryan Haight Act provides several exceptions that effectively allow a practitioner to engage in online prescribing through the practice of telemedicine without first performing an in-person medical evaluation. Specifically, the Act provides that a medical practitioner may engage in online prescribing without an in-person medical evaluation where the telemedicine services are:
- Rendered by a provider who is registered with the DEA to a patient who is physically located in a hospital or clinic that is also registered with the DEA;
- Rendered while the patient is being treated by, and in the physical presence of, another practitioner who is registered with the DEA;
- Rendered by an employee or contractor of the U.S. Indian Health Service, within the scope of such employment or contract, who satisfies certain eligibility criteria;
- Rendered during a public health emergency declared by the Secretary of Health and Human Services if the patient is located in the affected area;
- Rendered when the practitioner has obtained a special registration under the Act;
- Rendered in a medical emergency situation that prevents the patient from being in the physical presence of a practitioner who is an employee or contractor of the Veterans Health Administration, or that prevents the patient from being physically present at a Veterans Affairs hospital or clinic; or
- Rendered under any other circumstances the U.S. Attorney General and the Secretary of the Department of Health and Human Services have jointly authorized.
Only when a practitioner satisfies one of the above exceptions is the practitioner normally exempt from the in-person medical evaluation requirement.
DEA Proposed Rule
Note that the DEA published a notice of proposed rulemaking on February 26, 2020. Though the proposed rule anticipates lifting some restrictions on mobile health, it is narrow in that it only applies to substance abuse treatment and is not the rule that telehealth advocates hoped for.
Disappointed telehealth providers had been waiting for a permanent rule that would ease federal restrictions on the prescription of scheduled drugs via telemedicine. The Ryan Haight Act provides that the Attorney General may issue practitioners special registrations to engage in the practice of telemedicine if the practitioner (i) demonstrates a legitimate need for the special registration, (ii) is registered to prescribe controlled substances in the state in which the patient is located when receiving the telemedicine treatment, and (iii) maintains compliance with federal and state laws regarding controlled substances. While the Act further provides for the DEA to promulgate regulations on the registration procedures, the DEA has not issued regulation.
With the Special Registration for Telemedicine Act of 2018, which was part of the SUPPORT for Patients and Communities Act signed into law by President Donald Trump in late 2018, the DEA had until October 24, 2019 to set the ground rules for providers with a special registration to prescribe controlled substances. That deadline passed without action. In November, the Justice Department announced plans to issue a proposed rule to create that registration process, but nothing has occurred since then. The recent proposed rule failed to address this issue.
During the public health emergency due to COVID-19, practitioners may prescribe controlled substances through telemedicine technology without compliance with the Ryan Haight Act, and Texas is an example of a state that has issued a waiver based on the DEA announcement. In the long term, the Ryan Haight Act will continue to govern after the emergency is over, and telehealth advocates still wait for the DEA to issue regulations providing for a special registration process easing restrictions on the prescription of scheduled drugs via telemedicine.