With more than 35,000 comments combined, the US Drug Enforcement Administration’s (DEA) long-awaited proposed rules on controlled substance prescribing through telemedicine have drawn strong and widespread attention across the health care industry from patients, prescribers, and pharmacies.

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On March 1, 2023, the DEA issued 2 proposed rules, which would establish restrictions on telehealth consultations by a medical practitioner who has never conducted an in-person evaluation of a patient but that results in the prescribing of a Schedule III, IV, or V controlled substance. The first proposed rule applies to the prescribing of Schedule III-V non-narcotic controlled substances.

The second rule applies to Schedule III narcotics, specifically buprenorphine, a controlled substance used to treat opioid use disorder (OUD). The DEA intends to finalize both rules to go into effect at the end of the COVID-19 public health emergency (PHE), which expires on May 11, 2023. Although these rules coincide with the end of the pandemic and would therefore create post-pandemic policy, the DEA also considers these rules to satisfy their obligation from the 2008 Ryan Haight Act to create a special registration process for telemedicine.

Although there are some distinctions between the two proposed rules, both would generally restrict patients from obtaining controlled substances prescriptions without first receiving an in-person medical examination. Stakeholders are concerned that, if finalized in their current form, these proposed rules would restrict access to necessary and legitimate treatment.

This article will provide an overview of the requirements under the proposed rules, how these rules would impact pharmacy stakeholders, and what the public—specifically, the pharmacy industry—is saying about the proposed rules.

Telehealth Prescribing Under the Proposed Rules

The proposed rules would permit prescribers to use telemedicine to prescribe controlled substances only for legitimate medical purposes in the usual course of their professional practice, with some limitations. These limitations are more permissive than pre-pandemic DEA rules on telemedicine prescribing, but are more restrictive than the rules of the past 3 years during the COVID-19 PHE.

The proposed rules would permit a telehealth provider to prescribe only up to a 30-day supplyof a Schedule III-V non-narcotic controlled substance or buprenorphine through telehealth without the patient first being evaluated in person by a provider. To renew prescriptions of these controlled substances or to provide a prescription that exceeds the 30-day supply limitation, telehealth prescriberswould be required to satisfy the in-person evaluation requirement discussed in the next section.

Although under a separate rule, the proposed rule for prescribing buprenorphine is largely the same as the rules for other Schedule III-V non-narcotics. The main difference is that practitioners may prescribe buprenorphine using audio-only technology for the diagnosis, treatment, or evaluation of a mental health disorder. This prescribing would only be permitted when patients do not have access to, or do not consent to, the use of interactive video technology and only in states that do not prohibit the use of audio-only technology to prescribe buprenorphine for OUD.

Thus, under the proposed rules, telehealth providers would no longer be able to prescribe Schedule II controlled substances or Schedule III-V narcotics (with the sole exception of buprenorphine) without an in-person evaluation. Telehealth providers would be able to prescribe a 30-day supply through telemedicine without the initial in-person visit for buprenorphine and non-narcotic Schedule III-V.

To further address its concerns about potential diversion of controlled substances, the DEA would require a telehealth prescriber to review the prescription drug monitoring program (PDMP) database of the state in which the patient is located before prescribing controlled substances. If the PDMP is non-operational, the prescriber would be required to limit the prescription to a 7-day supply until the prescriber can obtain access to and review the patient’s information in the PDMP database.

In-Person Evaluation Requirements

To initiate a new prescription of a Schedule II-V controlled substance or continue prescribing buprenorphine and non-narcotic Schedule III-V controlled substances to patients beyond an initial 30-day supply, a telehealth prescriber would need to satisfy the requirement that a patient receive an in-person medical evaluation:

1. By conducting an in-person evaluation;
2. By being present using real-time, audio-visual communication when a patient is being examined in-person by another DEA-registered provider; or
3. By obtaining a qualifying telemedicine referral—that is, where another DEA-registered provider has already performed an in-person evaluation and subsequently refers the patient to the prescribing telehealth provider.

For telehealth consultations where a provider-patient relationship was established virtually during the COVID-19 PHE—specifically, on or before May 10, 2023—telehealth prescribers would be permitted to issue non-narcotic Schedule II-V controlled substances for an additional 180 days beyond the PHE’s expiration without having to meet the in-person evaluation requirement. However, to continue prescribing controlled substances after this 180-day extension for existing patients, prescribers would be required to meet the in-person evaluation requirement.

Documentation and Recordkeeping

The proposed rules would establishrequirements for documenting buprenorphine and Schedule III-V controlled substances prescriptions issued during a telemedicine encounter and maintaining records of these prescriptions, such as the date the prescription was issued, the name and address of the patient, the drug name, strength, and quantity, and the location of the practitioners and patient, among other requirements. Buprenorphine would be subject to additional documentation requirements. Practitioners would need to maintain records in electronic or paper form at the location listed on their DEA registration, regardless of whether the telemedicine encounter occurred elsewhere.

The DEA released resources to help stakeholders understand the requirements set forth in the proposed rules, including a patient flowchart, a practitioner prescribing chart, and a summary for practitioners of the proposed rules.

Timing

Both proposed rules provide for a 30-day comment period that would allow the agency approximately 6 weeks from the end of the comment period to review and respond to the more than 35,000 comments, and write and publish a final rule. Providers would then have to read and implement the final rule before the expiration of the COVID-19 PHE on May 11.

Many stakeholders, such as the American Telemedicine Association’s affiliated advocacy arm, ATA Action, have expressed concerns regarding this extremely abbreviated timeline that telehealth providers would not be adequately prepared to comply with the rule, causing patients to inevitably lose access to necessary telehealth services.

Pharmacy Stakeholder Concerns

1. Lack of Clarity Regarding Pharmacists’ Duty

The proposed rules, as drafted, focus on the requirements pertaining to telehealth prescribers, but do not contemplate the role of the pharmacist in this new scheme. Pharmacists have a corresponding responsibility to ensure that prescriptions are legitimate, but it is unclear under these rules to what extent pharmacists would be required or expected to ensure that prescribers have followed the rules specific to a telemedicine prescription.

The proposed rules would require telemedicine practitioners to: (1) after an initial 30-day supply, have an in-person visit or be referred to by an in-person provider, (2) make a notation on the face of the prescription that the prescription was issued via telemedicine; and (3) register with the DEA in the locations where both the prescriber and the patient are located at the time of service. However, the proposed rules fail to establish clear requirements for pharmacists or address how a pharmacist should properly verify a telehealth prescription for a controlled substance.

Under federal law, a pharmacist has a “corresponding responsibility” to ensure proper controlled substance prescribing and may be subject to penalties for failing to do so. DEA regulations provide:

• A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. § 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. (21 CFR § 1306.04(a) (emphasis added).

Under these requirements, the pharmacist has a duty to ensure that a prescription is valid and cannot simply work under the assumption that the prescriber has complied with their legal obligations. Most often, the pharmacy’s prescription software allows the pharmacist to verify the prescriber’s licensure status.

The proposed rules, however, would greatly complicate pharmacists’ ability to meet their obligations under the corresponding responsibility doctrine because the pharmacist would not be able to verify that the prescriber met any of the aforementioned requirements without reaching out to the prescriber to verify the information. This process would undoubtedly impact patient care and prolong the time it would take a pharmacist to dispense a prescription or may lead to the pharmacist rejecting the prescription outright.

Due to the lack of clarity on pharmacist responsibility, the proposed rules would likely cause more pharmacies to implement a blanket ban on filling telehealth prescriptions for controlled substances. Given that all telehealth prescriptions for controlled substances must include a notation that the prescription was issued via telemedicine, this outcome is easily foreseeable.

For example, Walmart Inc. and CVS Health Corp. have already indicated they will no longer fill controlled substance prescriptions issued by certain telehealth providers. The National Association of Boards of Pharmacy (NABP) also noted this concern in its comment to the DEA’s proposed rule and raised important questions that pharmacists will need to consider when reviewing a telehealth prescription for a controlled substance:

1. If a patient located in state A presents a prescription from a practitioner located in state B, and the prescription does not include a notation that it has been issued via telemedicine, then what level of due diligence must the pharmacist conduct to be assured that the prescription was not issued pursuant to a telehealth encounter?
2. If a pharmacist suspects that an initial 30-day controlled substance prescription was issued via telemedicine, but it is not notated as such, must the pharmacist then refuse to fill that prescription?
3. If a controlled substance prescription is labeled as a telemedicine prescription, must the pharmacist confirm that the following month’s prescription, from the same practitioner and for the same therapy, was issued pursuant to a provider referral or in-person examination by the prescriber provider?
4. When reviewing a telemedicine practitioner’s state licensure, which states must the pharmacist check? The state where the practitioner was located during the telemedicine encounter, the state where the practitioner operates their professional practice, the state where the patient was located during the telemedicine encounter, and/or the state where the pharmacy is located?

Under the proposed rules, the pharmacist, short of calling each individual prescriber and requesting documentation, would have no way of knowing whether the telehealth prescriber appropriately followed the rules to prescribe a controlled substance. In light of the DEA’s investigation into Truepill for wrongfully filling thousands of controlled substance prescriptions issued by telehealth providers, as well as the ongoing opioid epidemic, many pharmacists may not feel comfortable dispensing telemedicine prescriptions for controlled substances. Without clear guidance from the DEA on these pharmacy issues, the proposed rules would inevitably result in prescription denials, thereby reducing patient access to legitimate medications.

2. Potential Loophole to the “Initial Dispensing” Restriction

In its comment to the DEA, the NABP identified an issue that could lead to a patient obtaining controlled substances via telemedicine in excess of the 30-day “initial prescription” limit. As discussed above, the proposed rules would require a practitioner, when treating a new, non-referred patient via telemedicine, to limit the prescribing of a controlled substance to a 30-day supply.

The practitioner would then no longer be permitted to prescribe the same controlled substance to that patient until an in-person evaluation takes place. This approach, however, fails to take into consideration patients who have already recently received treatment with the same drug therapy from another telehealth practitioner.

In those instances, because the patient has already received the controlled substance from the first prescriber, the 30-day initial prescription issued by the next prescriber for the same therapy is no longer an “initial” therapy. By attaching the 30-day limitation to an individual practitioner, rather than to the therapy, the NABP argues that this structure would create a loophole, whereby a drug-seeking individual may be able to obtain a new “initial” prescription for a controlled substance simply by consulting with a new telemedicine practitioner. The DEA’s proposed rule does require the prescribing telehealth provider to review the PDMP database prior to issuing a controlled substance prescription, but this requirement may not be sufficient to address the NABP’s concern.

Now that the comment period is closed, clinicians who treat patients’ conditions with controlled substances and patients themselves are waiting with bated breath for the DEA’s final rules. Will the final rules be substantially similar to the proposed rules, which stakeholders fear would result in many patients losing access to care via telehealth?

Or will the final rules be significantly different, requiring providers and patients to pivot their compliance in a matter of days before May 11? Or, perhaps, will the DEA, the White House, or Congress decide that more time is necessary to finalize these important requirements and extend pandemic flexibilities for some period of time until the DEA can resolve the details?

We will find out soon enough given that May 11 is quickly approaching. However, equally if not more concerning to stakeholders anxiously anticipating these rules would be a reality in which the DEA reverts back to pre-pandemic rules, placing even more restrictions on telemedicine than what is proposed.