The Wait Is Over . . . Or Is It? DEA’s Proposed Rules Around Telemedicine Prescribing: Initial Impressions and Key Takeaways

On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced proposed permanent rules around prescribing controlled substances via telemedicine that expand the circumstances under which practitioners can prescribe controlled substances without first conducting an in-person medical evaluation of the patient outside of the COVID-19 public health emergency (“PHE”). The proposed rules are more restrictive than the DEA emergency waivers under which providers conducted telemedicine prescribing for the last three years, but are less restrictive in comparison to the pre-PHE regulations applicable to telemedicine prescribing of controlled substances under the federal Controlled Substances Act (“CSA”).

Both the proposed rules related to telemedicine prescribing of Schedule III-V non-narcotic controlled substances, and the separate proposed rules related to telemedicine prescribing of buprenorphine, were published in the Federal Register on March 1, 2023. The public has been given until March 31, 2023 to review and provide comments regarding the proposed rules, which the DEA will consider before promulgating final regulations.

In this post, we will share initial impressions regarding DEA’s proposed rules, and we will discuss key implications and takeaways for various stakeholder groups and identify areas where the stakeholders may want to consider providing comments to the DEA.

At a high-level, the proposed rules add three (3) additional circumstances to the existing and narrow set of instances where a DEA-registered practitioner can prescribe controlled substances without having personally conducted an in-person medical examination of a patient. Where the issuance of a prescription is otherwise consistent with applicable federal and state laws, the proposed rules would allow practitioners to:

1. Prescribe up to a 30-day supply of Schedule III-V non-narcotic controlled medications,
2. Prescribe up to an initial 30-day supply of buprenorphine for the induction of treatment of opioid use disorder, and
3. Prescribe any schedule of controlled medication, including narcotics, where there has been a qualifying telemedicine referral from a practitioner who has conducted an in-person medical evaluation of the patient.

Additional criteria and limitations apply in the context of these proposed rules, including new and modified administrative and record-keeping requirements. These considerations are described further below.

Notably, the proposed rules also give DEA-registered practitioners who have relied on the DEA’s emergency waiver—which, since January 2020, has allowed practitioners to prescribe Schedules II-V controlled substances without conducting a prior in-person medical evaluation of the patient—up to 180 days to come into compliance with the new in-person evaluation requirements that would be implemented in the final regulations.

Background on the Ryan Haight Act

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) made certain amendments to the CSA which established controls on the remote prescribing of controlled substances. Generally, the Ryan Haight Act amendments require that, in order for a controlled substance prescription issued via the internet to be “valid” it must be issued for a legitimate medical purpose by a practitioner who is acting in the usual course of his/her professional practice and who has conducted at least one (1) in-person medical evaluation of the patient, unless a narrow exception applies. 18 U.S.C. § 829.

As background, the Ryan Haight Act amendments to the CSA were enacted to combat unsafe dispensing practices of online pharmacies and their affiliated prescribers, including the unnecessary and inappropriate prescribing of controlled substances, and to curtail the ease of accessing controlled substances via the Internet, especially by young adults. See H. Rept. 110-869. The Ryan Haight Act amendments were not designed with the current state of the industry in mind, and as such do not contemplate how the practice of telemedicine has developed and expanded in recent years to accommodate a range of physical and mental health treatments. Indeed, since the January 2020 declaration of the PHE, telemedicine has become a preferred method for many patients to access their health care providers, a significant example being increased access to mental health treatment.

Exceptions to the in-person evaluation requirement have traditionally existed, but only in a narrow set of circumstances, such as when a practitioner is covering for another practitioner who has conducted an in-person examination of the patient within the previous two (2) years (i.e., a cross-coverage situation), or where a practitioner is engaged in the “practice of telemedicine,” e.g. because the patient was physically located in a DEA-registered hospital, clinic, or physician’s office. 21 U.S.C. § 802(54). The Ryan Haight Act authorized (and arguably directed) DEA to create a special registration process for prescribers of controlled substances via the internet. Since that time, however, despite attempts by members of Congress to petition DEA to initiate that rulemaking process, there was no meaningful movement. In 2018, Congress passed requirements under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act, requiring DEA to create a special registration for opioid addiction treatment via telehealth by October 2019. This deadline came and went, also without meaningful action taken by DEA.

Telemedicine Prescribing During the COVID-19 PHE

During the COVID-19 PHE, among many other regulatory flexibilities, federal and state prescribing requirements were relaxed. The relaxing of such requirements made it easier for health care providers to prescribe both controlled and non-controlled substances to patients without ever conducting an initial in-person visit with the patient prior to issuing the prescription. Incidentally, telemedicine prescribing activities increased across the health care industry. Until the expiration of the federal PHE, set for May 11, 2023, the DEA has allowed DEA-registered practitioners to operate under an emergency waiver in order to prescribe controlled substances without ever having conducted an in-person visit with the patient, provided other criteria were satisfied (including that the practitioner conducted an evaluation of the patient via telemedicine using a synchronous, two-way, audio-visual communications device).

Without final DEA rulemaking, at the end of the PHE, federal controlled substance prescribing requirements will revert to their pre-pandemic state. Therefore, DEA’s proposed permanent rules around prescribing controlled substances via telemedicine are welcomed by many to permanently extend telemedicine prescribing flexibilities.

DEA’s Proposed Telemedicine Prescribing Rules: An Overview

Pursuant to the authority granted in 21 U.S.C. § 802(54)(G), the proposed rules would add additional circumstances that would qualify as the “practice of telemedicine,” which would in turn allow health care providers to prescribe controlled substances based on telemedicine encounters and without personally conducting an in-person medical evaluation of the patient. However, such prescribing activities would be limited under the new rules to non-narcotic Schedule III-V controlled substances, a limitation not expressly included in the special registration provisions of the Ryan Haight Act.

In summary, DEA’s proposed rules would, under certain circumstances, allow practitioners to: (1) prescribe up to a thirty (30) day supply of Schedules III-V non-narcotic controlled medications, (2) prescribe up to a thirty (30) day supply of buprenorphine for the treatment of opioid use disorder, and (3) prescribe any schedule of controlled medication, including narcotics, where there has been a “qualifying telemedicine referral” from a practitioner who has conducted an in-person medical evaluation of the patient.

In the first two circumstances described, in order to prescribe any amount of a controlled substance beyond the thirty (30) day supply, the practitioner would be required to conduct a medical examination, which could be accomplished through a traditional in-person examination, or via an audio-visual interactive telecommunications system where the patient is in the physical presence of another DEA-registered practitioner. A practitioner could also continue prescribing pursuant to a qualifying “telemedicine referral,” where the patient has already received a related in-person medical evaluation from the referring practitioner.

The proposed rules impose specific record-keeping requirements on prescribing practitioners related to such medical examinations, as well as on any practitioners who participate in facilitating the medical examination through interactive telecommunications systems.

The proposed rules also clarify that a telemedicine encounter that results in a controlled substance prescription requires the health care professional treating the patient to use an interactive telecommunications system, and directly refers to the Medicare definition of that term at 42 C.F.R. § 410.78(a)(3). An interactive telecommunications system uses audio and video equipment that permits two-way, real-time interactive communication between the patient and the distant site practitioner. However, the proposed rules also indicate that for services provided for purposes of diagnosing, evaluating, or treating mental health disorders, including opioid use disorder (“OUD”), where a patient is located in his/her home, these services can be provided through audio-only exchanges so long as the practitioner is technically capable of meeting the audio-visual standard but the patient is either incapable of using, or the patient does not consent to the use of, video technology.

DEA has taken a bifurcated approach in describing its proposals with respect to telemedicine prescribing of controlled substances (generally) and telemedicine prescribing of buprenorphine. In both regards, DEA’s proposed rules limit the prescribing of certain controlled substances via telemedicine (by limiting the ability to prescribe Schedule II controlled substances and narcotic Schedule III-V medications). These limitations curtail what has been permissible during the PHE and arguably exceed what Congress has authorized under the Ryan Haight Act as amended by the SUPPORT Act. We will address each of these proposed regulatory schemes in turn.

Proposed Requirements for Telemedicine Prescribing of Non-Narcotic Schedule III-V Controlled Substances

Under the proposed rules for telemedicine prescribing of non-narcotic Schedule III-V controlled substances, DEA outlines the specific circumstances under which a practitioner may prescribe up to a thirty (30) day supply of these medications without conducting an in-person evaluation of the patient prior to issuing the prescription. These requirements would be included at 21 C.F.R. § 1306.31 and such prescriptions would be referred to in the new rules as “telemedicine prescriptions” – a new term of art created by the rules. In order for a practitioner to issue a telemedicine prescription, all of the following conditions would need to be met:

• The prescription must be issued pursuant to a telemedicine encounter, for a legitimate medical purpose, by a practitioner acting in the usual course of his/her professional practice;
• The prescription must arise out of a telemedicine communication that occurs directly between the prescribing practitioner and that patient;
• The practitioner must be located within the United States;
• The practitioner must be authorized to prescribe the basic class of controlled substances under that practitioner’s DEA registration;
• The prescription must clearly indicate that it is being issued based on a telemedicine encounter.

The proposed rule also would require practitioners to review and consider the prescription drug monitoring program (“PDMP”) data in the State where the patient is located, provided the State has such a program. In the event that the PDMP data is inaccessible because of technical issues, the practitioner only would be permitted to prescribe a seven (7) day supply of the qualifying controlled substance, and additional procedural requirements would apply including continued attempts by the practitioner to access the PDMP data, and completion of appropriate documentation of those attempts.

The proposed rule also would institute specific record-keeping requirements for all practitioners issuing telemedicine prescriptions.

Proposed Requirements for Telemedicine Prescribing of Buprenorphine

Under the proposed rules for telemedicine prescribing of buprenorphine (a Schedule III opioid), DEA outlines the specific circumstances under which a practitioner may initiate or induce treatment with buprenorphine by prescribing up to a thirty (30) day supply of buprenorphine for the treatment of opioid use disorder without conducting an in-person evaluation of the patient prior to issuing the prescription.[1] As proposed, in order for a practitioner to issue an initial buprenorphine prescription via a telemedicine encounter, all of the following conditions must be met:

• The practitioner is registered in the State where the practitioner is located at the time of the encounter;
• The practitioner is authorized by State law to engage in the practice of telemedicine in both the state where the practitioner is located and in the state where the patient is located;
• The practitioner is authorized under 21 C.F.R. § 1301.28 to provide medication assisted treatment (“MAT”);[2]
• The practitioner has the technical capabilities to use audio and video equipment permitting two-way, real-time interactive communication with the patient; and,
• The practitioner reviews and considers PDMP data in the state where the patient is located. Specific procedures and limitations related to the unavailability of PDMP data also would apply.

However, to continue to participate in medication-assisted treatment with buprenorphine, the proposed rules would require the patient to receive an in-person medical evaluation meeting certain requirements within thirty (30) days of the initial buprenorphine prescription. This evaluation would be required to occur either: (1) in physical presence of the prescribing practitioner or practice, (2) in the physical presence of another DEA-registered practitioner participating in an audio-video telemedicine encounter with the prescribing practitioner, or (3) pursuant to a qualifying “telemedicine referral” for medically-assisted treatment for opioid use disorder (where the patient has already received an in-person medical evaluation from the referring practitioner, as discussed further in the next section below).

Thus, although the proposed rule would facilitate the ability of patients with opioid use disorder (“OUD”) to initiate treatment with buprenorphine, the proposed rule would eliminate current flexibilities under the COVID-19 PHE for patients to participate in MAT without an in-person visit to a provider. This means that providers that expanded their telehealth operations during the PHE will no longer be allowed to continue to operate in geographies where they do not have physical locations or referral relationships, and that patients that are unable or unwilling to travel to in-person appointments will lose access to treatment.

The proposed rule also would institute specific record-keeping requirements for all practitioners issuing buprenorphine prescriptions via telemedicine.

Proposed Requirements for Prescribing Pursuant to a “Qualifying Telemedicine Referral”

The proposed rules allow practitioners to prescribe controlled substances based on telemedicine encounters without personally conducting an in-person medical evaluation of the patient, where there has been a “qualifying telemedicine referral”. The prescribing practitioner is permitted to rely on the referring practitioner’s in-person medical evaluation in order to prescribe the controlled substance via telemedicine. In such a case, the prescribing practitioner can prescribe any controlled substance via telemedicine that they are otherwise authorized to provide under federal and state law, including Schedule II controlled substances, and narcotics, and there is no requirement that the prescription be limited to a thirty (30) day supply.

As proposed, a qualifying telemedicine referral is a referral from a practitioner that has conducted at least one in-person medical evaluation of the patient, where the referral is for a legitimate medical purpose, and made in the ordinary course of the referring practitioner’s professional practice. The referral itself must specifically include the name and National Provider Identifier (“NPI”) of the practitioner to whom the patient is being referred. The referral must be based on the diagnosis, evaluation, or treatment that was provided for the medical issue upon which the medical evaluation was predicated, and the referring practitioner is required to provide the results of the medical evaluation to the prescribing practitioner before the prescribing practitioner issues the prescription. In the context of prescribing buprenorphine for opioid use disorder, the referral must be for MAT of opioid use disorder from a DEA-registered practitioner.

Importantly, where a prescription is predicated on a “qualifying telemedicine referral” it also qualifies as a “telemedicine prescription” and thus the standards for telemedicine prescribing outlined above apply, as do additional record keeping requirements.

Key Implications and Takeaways from the Proposed Rules

DEA welcomes comments from all parts of the industry and, in fact, has specifically requested comments on the following questions and concerns:

1. Are additional clarifications in the final rules warranted to ensure appropriate access to care, consistency with effective controls against diversion, and consistency with public health and safety considerations?
2. Should the final rules limit the issuance of prescriptions of controlled medications to the FDA-approved indications contained in the FDA-approved labeling for those medications?
3. Are the proposed record-keeping obligations reasonable and/or sufficient?
4. Based on resources including data from research and/or actual clinical practice, would an alternate maximum day supply be more appropriate than the 30-day maximum supply proposed in the rulemaking?
5. Do the identified harms of buprenorphine diversion, as experienced during the waiver of in-person examination requirements during the COVID-19 PHE, outweigh the barrier to access that is created by the reinstatement of such requirements?
6. Are there any additional safeguards or flexibilities that should be considered?

Other Considerations Not Addressed by DEA’s Proposed Rules

In addition to the questions that DEA has specifically asked for comment on, industry members who may be impacted by DEA’s proposed rules should consider commenting within the 30-day period, on issues such as the following:

• DEA State-Specific Registration Requirements. Neither DEA’s proposed rules nor the preamble to those rules squarely address DEA’s longstanding interpretation that a practitioner must obtain a separate DEA registration in each state where that practitioner dispenses a controlled substance? During the PHE, DEA Policy provided an exception to the separate registration requirement for practitioners seeking to prescribe across state lines, provided such prescribing was authorized by state law. In the proposed rules regarding buprenorphine DEA says that a practitioner must be registered in the state where he/she is located, however, DEA does not address this issue in its proposed rules governing the special registration requirements generally. This begs the question of whether DEA has changed its longstanding position and/or whether the special registration will supplant the need to obtain a DEA registration in multiple states.

• Provider Education and Understanding About New Prescribing and Recordkeeping Requirements. DEA’s proposed rules may be a positive step in the right direction for the telemedicine industry; however, the proposed rules also would impose significant new compliance obligations on providers which, in turn, may impose implementation challenges. For example, will prescribers be able to readily determine what is a “narcotic”[3] versus a “non-narcotic” (an important distinction because different standards apply)? Will DEA provide any further guidance to assist providers with these types of determinations or how to comply with the new recordkeeping obligations?

• Impact On Off-label Prescribing of Controlled Substances. DEA has specifically requested feedback on whether it should limit telemedicine prescribing to only the drug’s FDA-approved indications. However, it is unclear whether the CSA, as amended by the Ryan Haight Act, would authorize such a limitation. Also, even if permitted, such a limitation may be at odds with DEA’s historic treatment of unapproved new drugs, including the issuance of DEA registrations and quotas to manufacturers and distributors of such drugs.

• Referral Relationship Considerations. As written, a potential incentive under the proposed DEA rules is to create referral relationships with primary care and other types of providers, to facilitate compliant telehealth prescribing activities. These types of relationships can raise unique fraud and abuse issues and therefore require careful planning and structuring. Will DEA suggest through its guidance any guardrails for the industry to consider? Will OIG?

• Impact on Pharmacies. Although the proposed rules impose requirements on the practitioners that prescribe controlled substances and not pharmacists, under DEA regulations pharmacists have a “corresponding responsibility” to ensure prescriptions are legitimate.[4] The U.S. Department of Justice has repeatedly sought to hold pharmacies that dispense controlled substance prescriptions despite the presence of “red flags” accountable under theories that filling such prescriptions result in diversion under the CSA[5] and/or false claims under the federal False Claims Act.[6] Recently, DEA scrutiny has included telehealth companies that prescribe controlled substances and the pharmacies that fill them.[7] Considering the current enforcement environment and increasing burden on pharmacists to scrutinize controlled substance prescriptions, pharmacies and pharmacists would have legitimate concerns on how the proposed rules would impact the pharmacist’s “corresponding responsibility” obligations. Notably, the proposed rules will require prescriptions to clearly indicate they were issued based on a telemedicine encounter. Pharmacies may want to address in comments what “unsaid” expectations the proposed rules place on a pharmacist to verify compliance with the new rules. For example, any expectation that a pharmacist would verify the existence of a “qualifying telemedicine referral” would likely add more confusion and complexity to an already burdensome process.

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Contact the authors of this post if EBG can be helpful in thinking through DEA’s proposed rules and, importantly, preparing comments to make your concerns and questions known to DEA.

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[1] The proposed rule also would allow practitioners to prescribe any other Schedule III-V narcotic drug that becomes approved by the Food and Drug Administration (“FDA”) for use in the maintenance or detoxification treatment of OUD, should any such additional drugs be approved.

[2] Note that Section 1262 of the Consolidated Appropriations Act of 2023 removes the federal requirement for practitioners to submit a Notice of Intent (i.e., have an X-waiver) to prescribe medications, like buprenorphine, for the treatment of OUD, as currently required under 21 C.F.R. § 1301.28. Presently, all practitioners who have a current DEA registration that includes Schedule III authority may prescribe buprenorphine for Opioid Use Disorder in their practice if permitted by applicable state law and the federal Substance Abuse and Mental Health Services Administration (“SAMHSA”) encourages them to do so. SAMHSA and DEA are actively working on implementation of a separate provision of the Omnibus related to training requirements for DEA registration that becomes effective in June 2023.

[3] Under the CSA, “narcotic” drugs are defined as drugs containing opiates, cocaine, or ecgonine, as well as certain related plant materials. 21 U.S.C. § 802(17). While DEA has provided examples of Schedule II and III narcotic medications, to our knowledge, DEA has not published a complete list, and some providers may have difficulty understanding and readily applying the CSA’s definition.

[4] 21 C.F.R. § 1306.04(a).

[5] U.S. Department of Justice, Press Release, U.S. Attorneys Andrew Birge and Matthew Schneider Announce Record-Setting Drug Diversion Civil Penalty Settlement with McClaren Health Care Corporation (Jan. 19, 2021), https://www.justice.gov/usao-edmi/pr/us-attorneys-andrew-birge-and-matthew-schneider-announce-record-setting-drug-diversion.

[6] U.S. Department of Justice, Press Release, Pharmacist to Pay $275,000 to Settle Claims Related to the Alleged Unlawful Dispensation of Controlled Substances (Nov. 15, 2021), https://www.justice.gov/usao-sdga/pr/pharmacist-pay-275000-settle-claims-related-alleged-unlawful-dispensation-controlled.

[7] U.S. Drug Enforcement Administration, Press Release, DEA Serves Order to Show Cause on Truepill Pharmacy for its Involvement in the Unlawful Dispensing of Prescription Stimulants (Dec. 15, 2022), https://www.dea.gov/press-releases/2022/12/15/dea-serves-order-show-cause-truepill-pharmacy-its-involvement-unlawful.