On March 1, 2023, the Drug Enforcement Administration (DEA) released the proposed rule, “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation.” The proposed rule would add provisions to the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “RHA”) regarding telemedicine prescribing of Schedule III-V non-narcotic controlled substances. The RHA is, in turn, an amendment to the Controlled Substances Act. While many hoped this rule would finally set forth the “special registration” framework promised by the original RHA, it instead proposes a labyrinth of definitions and new rules.

The DEA frames the proposed rule as “adding several new provisions to prevent the illegal distribution and dispensing of controlled substances by means of the internet” and characterizes it as applying only in “limited circumstances” when the prescribing practitioner wishes to prescribe controlled medications via telemedicine without an in-person examination. However, due to the impact of COVID-19, absence of an in-person requirement is far from a “limited” occurrence.

The DEA claims promulgation of the proposed rule is a logical step in effectuating the RHA’s purpose. One of these purposes was to halt “rogue websites [that] fueled the misuse of controlled prescription medications, such as hydrocodone and oxycodone, thereby contributing to increased drug poisonings and other harmful health, social, and economic consequences.”  Ultimately, the DEA hopes to use the proposed rule as another mechanism to increase its control over the dispensation of controlled substances. The proposed rule’s language reflects this bent towards control, sweeping smaller practitioners prescribing controlled substances into the DEA’s broad mission of curbing narcotic distributions. The proposed rule applies the same to all types of providers prescribing controlled substances, seemingly without taking the nature of smaller providers’ (e.g., wellness practitioners) unique position of prescribing less harmful drugs, and for permissible purposes, into account.

Summary of the Proposed Rule

Two major parts form the proposed rule: definitions and new regulations for practitioners prescribing controlled substances.

Three of the new definitions are significant to practical application of the proposed rule. First, “qualifying telemedicine referral” means “a referral to a practitioner that is predicated on a medical relationship that exists between a referring practitioner and a patient where the referring practitioner has conducted at least one medical evaluation in the physical presence of the patient, without regard to whether portions of the evaluation are conducted by other practitioners, and has made the referral for a legitimate medical purpose in the ordinary course of their professional practice. A qualifying telemedicine referral must note the name and National Provider Identifier of the practitioner to whom the patient is being referred.” Second, “telemedicine encounter” means “a communication between a practitioner and a patient using an interactive telecommunications system referred to in 42 CFR 410.78(a)(3)”. Third, “telemedicine relationship established during the COVID-19 public health emergency” means “(1) the practitioner has not conducted an in-person medical evaluation of the patient; (2) the practitioner has prescribed one or more controlled substances based on telemedicine encounters during the [PHE]….; and (3) no more than 180 days have elapsed since [EFFECTIVE DATE OF RULE] or the end of the nationwide public health emergency… whichever is later.”

What Are the Permissible Options for Prescribers under the Proposed Rule?

The proposed rule states that a practitioner may only use telemedicine to issue a prescription if: (1) the prescription is issued pursuant to a telemedicine encounter; (2) the prescription is for a legitimate medical purpose; and (3) the practitioner is acting in the usual course of professional practice. Practically, the proposed rule sets forth three ways to effectuate a permissible telemedicine encounter under the RHA:

1. The practitioner complies with the in-person requirement present in the original RHA.

2. A DEA practitioner (called the “referring practitioner” in the proposed rule) meets with the patient in the patient’s physical presence, while the prescribing practitioner “attends” this meeting via live, audiovisual technology.

3. A DEA practitioner (still called the “referring practitioner”) meets with the patient in the patient’s physical presence. The DEA practitioner then issues a qualifying telemedicine referral (defined above) that allows the prescribing practitioner to prescribe the controlled substance.

The contours of each option to comply with the RHA are outlined below.

The Traditional “In-Person” Requirement

As a quick reminder, the RHA states that no controlled substance that is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act may be delivered, distributed, or dispensed by means of the Internet without a valid prescription. A valid prescription means a prescription issued for a legitimate medical purpose in the usual course of professional practice by a practitioner who has conducted at least one in-person medical evaluation of the patient. Thus, if a practitioner prescribes a controlled substance after at least one in-person evaluation, the practitioner complies with the RHA.

The “Zoom” Option

The second option to prescribe a controlled substance via the practice of telemedicine is best understood as a “Zoom” option, because the prescribing practitioner must be connected to the patient’s appointment in real time, using audiovisual technology (such as Zoom). Under the proposed rule’s Section 1306.31(d)(2), the interaction between patient and practitioners involves (1) the patient; (2) in the physical presence of a DEA registered practitioner (the “referring practitioner”); and (3) the prescribing practitioner simultaneously on an audiovisual conference with the patient and referring practitioner. In following these three steps, the prescribing practitioner may then prescribe a controlled substance because a proper telemedicine encounter has taken place.

The Qualifying Telemedicine Referral Option

The qualifying telemedicine referral option also has three components. In order to properly perform the qualifying telemedicine referral option (1) the patient; (2) must be in the physical presence of a DEA registered practitioner (the “referring practitioner”); and (3) the referring practitioner must execute a qualifying telemedicine referral. In order to properly execute a qualifying telemedicine referral, the referring practitioner must issue the qualifying telemedicine referral in writing, the referring practitioner must report the patient’s results and diagnosis to the prescribing practitioner before the prescribing practitioner issues the prescription, and the referring practitioner must have issued the prescription on an actual investigation of the diagnosis. A proper qualifying telemedicine referral exists when all of these requirements are met.

The “Starter Pack”

The proposed rule provides an exception to the general options outlined above that is akin to a “starter pack.” Section 1306.31(c)(2) of the proposed rule allows a “time limited” 30-day prescription for each patient. Practitioners could prescribe controlled medications to a patient using telemedicine only for a period of 30 days before the practitioner performs an in-person medical evaluation. The prescribing practitioner would be permitted to issue multiple prescriptions for the patient, provided the prescriptions do not authorize the dispensing of more than a total quantity of a 30-day supply of the controlled medication. As such, this provision acts as a one-time “starter pack,” allowing the practitioner to delay compliance with the three options above for 30 days. However, in order to prescribe the controlled medication after 30 days from the issuance of its first prescription (i.e., the 30-day prescription has been used), the practitioner must perform either the in-person examination or one of the options allowed by the proposed rule.

What Other Aspects of Telemedicine Does the Proposed Rule Regulate?

The proposed rule also sets forth practitioner documentation and administrative requirements beyond the framework of options to comply with the RHA telemedicine requirements. These rules include:

• Practitioners must keep an electronic log for each prescription issued via a telemedicine encounter, including the information that would allow a circumstance to qualify as a “qualifying telemedicine referral.”

• Both the remote prescriber and the referring physician must keep records of the creation of the qualifying telemedicine referral.

• All of the records required by the proposed rule must be maintained at the address of the practice’s DEA-registered dispensing location.

• A practitioner may not use telemedicine to prescribe controlled substances while the practitioner is outside of the U.S.

• A practitioner must be authorized to practice via telemedicine both in the state where the practitioner is located and where the patient is located.

• A practitioner must review the state’s Prescription Drug Monitoring Programs for a patient’s substance history before prescribing that patient controlled substances.

• Section 1306.31(e)(1) serves as the proposed rule’s enforcement provision. If the prescribing practitioner does not conduct a medical evaluation as described in proposed paragraphs (d)(1) (original in person requirement) or (d)(2) (“Zoom” option), within a period of 30 calendar days, the practitioner would not be authorized to issue any subsequent prescriptions to that patient under proposed paragraph (f).

If a patient and practitioner meet the relationship defined by the phrase “telemedicine relationship established during the COVID-19 PHE,” the DEA will extend the in-person exam waiver an additional 180 days from the later of the published final rule or PHE expiration. After this date, a practitioner must meet a patient in person, meet either the “Zoom” option or qualifying telemedicine referral option above, or stop prescribing for the patient. Thus, the COVID-19 telemedicine relationship only kicks the compliance requirements down the road, but after three months, the fact that a practitioner established a relationship with a patient during COVID-19 will no longer play a role in the analysis.

How Will the Proposed Rule Impact Controlled Substances Prescribers?

While the proposed rule does clarify how to properly effectuate a telemedicine encounter post-PHE, it leaves gray areas for controlled substance prescribers. For example, the administrative requirements, such as notating on the prescription whether it was prescribed via telemedicine, causes practical issues. What is the notation to look like on the physical prescription versus practitioner records? How are the referring practitioner and prescribing practitioner to document communication when working together to achieve a qualifying telemedicine referral? Further, does certain communication need to take place between the prescribing practitioner and the DEA practitioner during the encounter, and what voice does the prescribing practitioner get in diagnosis? Further, is this the DEA’s final answer to the special registration process promised by the RHA? As written, the proposed rule falls far from the act of “registering,” but rather requires a restructuring of practitioner operations.

Further, in the proposed rule’s economic report, smaller prescribing entities appear to fall through the cracks because the administrative and telemedicine requirements will have a disproportionate impact on practices with less practitioners available to perform the in-person examination. It remains to be seen whether the proposed rule could serve to push these practices out of the marketplace and whether this could be an intention of the FDA as it attempts to control prescriptions of controlled medications. A registration in its truest form could be an answer to bridge the gap between practices of all sizes. Nevertheless, because the proposed rule poses examples and options for compliance under the RHA telemedicine requirements, practices of all sizes and disciplines should seek to structure their operations according to one of the options above should the proposed rule pass as written.