Special Registrations for Telemedicine and Limited State Telemedicine Registrations

Federal RegisterJan 17, 2025

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1304, and 1306

[Docket No. DEA-407]

RIN 1117-AB40

Special Registrations for Telemedicine and Limited State Telemedicine Registrations

AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Notice of proposed rulemaking.

SUMMARY:

The

Ryan Haight Online Pharmacy Consumer Protection Act of 2008

(the “

Ryan Haight Act”

) generally requires an in-person medical evaluation prior to the issuance of a prescription of controlled substances but provides an exception to this in-person medical evaluation requirement where the practitioner is engaged in the “practice of telemedicine” within the meaning of the

Ryan Haight Act.

These proposed regulatory changes would establish a Special Registration framework and authorize three types of Special Registration. This proposed rulemaking also provides for heightened prescription, recordkeeping, and reporting requirements. DEA believes such changes are necessary to effectively expand patient access to controlled substance medications via telemedicine while mitigating the risks of diversion associated with such expansion. A summary of this rule may be found at

https://www.regulations.gov/docket/DEA-2023-0029.

DATES:

Electronic comments must be submitted, and written comments must be postmarked, on or before March 18, 2025. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. All comments concerning collections of information under the

Paperwork Reduction Act

must be submitted to the Office of Management and Budget (OMB) on or before March 18, 2025.

ADDRESSES:

To ensure proper handling of comments, please reference “Docket No. DEA-407” on all correspondence, including any attachments.

•

Electronic comments:

DEA encourages that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type comments directly into the comment field on the web page or to attach a file containing comments. Please go to

http://www.regulations.gov

and follow the online instructions at that site for submitting comments. Upon completion of your submission, you will receive a Comment Tracking Number for your comment generated by

http://www.regulations.gov.

Please be aware that submitted comments are not instantaneously available for public view on

http://www.regulations.gov.

If you have received a Comment Tracking Number, your comment has been successfully submitted, and there is no need to resubmit the same comment.

•

Paper comments:

Paper comments that duplicate the electronic submission are discouraged. Should you wish to mail a paper comment

in lieu of

submitting a comment electronically, it should be sent via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. Hand-delivered comments will not be accepted.

•

Paperwork Reduction Act Comments:

All comments concerning collections of information under the

Paperwork Reduction Act

must be submitted to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, Washington, DC 20503. Please state that your comment refers to RIN 1117-AB40/Docket No. DEA-407.

FOR FURTHER INFORMATION CONTACT:

Heather E. Achbach, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 776-3882.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

Please note that all comments received, including attachments and other supporting materials, in response to this docket are considered part of the public record. The Drug Enforcement Administration (DEA) will make all comments available for public inspection online at

http://www.regulations.gov.

The

Freedom of Information Act

applies to all comments received. Confidential information or personal identifying information (PII), such as account numbers or Social Security numbers, or names of other individuals, should not be included. Submissions will not be edited to remove any identifying or contact information.

Comments with confidential information, which should not be made available for public inspection, should be submitted as written/paper submissions. Two written/paper copies should be submitted. One copy will include the confidential information with a heading or cover sheet that states “CONTAINS CONFIDENTIAL INFORMATION.” DEA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy should have the claimed confidential information redacted/blacked out. DEA will make this copy available for public inspection online at

http://www.regulations.gov.

Other information, such as name and contact information, that should not be made available, may be included on the cover sheet but not in the body of the comment, and must be clearly identified as “confidential.” Any information clearly identified as “confidential” will not be disclosed except as required by law.

Overview

I. Executive Summary

II. Legal Authority and Background

III. Need for Further Rulemaking:

Special Registration

IV. Section-by-Section Discussion of Proposed Rule

A. Registration Requirements Under 21 CFR Part 1301

1. Three Types of

Special Registration

and Eligibility of

Clinician Practitioners

and

Platform Practitioners

Telemedicine Prescribing Registration

Eligibility

Advanced Telemedicine Prescribing Registration

Eligibility

Telemedicine Platform Registration

Eligibility

2. Ancillary Registrations:

State Telemedicine Registrations

Special Registration

Application Process

Special Registration

Application, Cycles, and Fees

b. Supplemental

Special Registration

Application Requirements (

Form 224S

)

c. Notification of Changes to Application Information and Other Modifications (

Form 224S-M

)

Special Registration

Actions

a. Approvals and Denials of

Special Registration

Applications

b. Suspension and Revocations of

Special Registrations

Special Registration Prescriptions

Issued by

Clinician Special Registrants

under 21 CFR part 1306

1. Manner of Issuance of

Special Registration Prescriptions

2. Additional Elements on a

Special Registration Prescription

C. Recordkeeping and Reporting Under 21 CFR Part 1304

1. Patient Verification Photographic Records

Special Registration

Telemedicine Encounter Records

3. Credentials Verification and Conduct-Related Documentation Records

4. Centralized Recordkeeping at the

Special Registered Location

5. Pharmacy and Special Registrant Reporting of

Special Registration Prescription

Data

Individual Special Registrant

Reporting of Aggregated

Special Registration Prescription

Data

D. Regulatory Definitions Under 21 CFR Part 1300

E. Request for Comments

V. Regulatory Analyses

I. Executive Summary

The

Ryan Haight Online Pharmacy Consumer Protection Act of 2008

(the “

Ryan Haight Act

”), amended the Controlled Substances Act (CSA) by, among other things, requiring all prescription drugs which are dispensed by means of the

internet

be issued as a “valid prescription.”

Generally, a valid prescription requires, at a minimum, at least one “in-person medical evaluation,”

which is issued for a legitimate medical purpose in the usual course of professional practice.

The

Ryan Haight Act

does, however, provide an exception to this in-person medical evaluation requirement, when the practitioner is “engaged in the practice of telemedicine.”

Italicized terms indicate that it is a proposed term defined by the NPRM or a term currently defined in the CSA or DEA's regulations.

21 U.S.C. 829(e)(1).

21 U.S.C. 829(e)(2)(B)(i).

21 U.S.C. 829(e)(2)(A)(i).

21 U.S.C. 829(e)(3)(A).

The

Ryan Haight Act

provides seven (7) distinct categories of the

practice of telemedicine

in which a prescribing practitioner need not satisfy the

Ryan Haight Act's

in-person medical evaluation requirement, yet nonetheless may be able to prescribe a controlled substance for a legitimate medical purpose in the usual course of professional practice.

In these circumstances, provided certain safeguards are in place to ensure that the practitioner who is engaged in the

practice of telemedicine

is able to conduct a

bona fide

medical evaluation of the patient at the remote location, and is otherwise acting in the usual course of professional practice, the

Ryan Haight Act

contemplates that the practitioner will be permitted to prescribe controlled substances by means of the

internet

despite not having conducted an in-person medical evaluation.

21 U.S.C. 802(54).

Thus far, DEA has permitted, or promulgated regulations to permit, the

practice of telemedicine

pursuant to two of the seven categories of telemedicine authorized under the

Ryan Haight Act.

In March 2020, in response to the COVID-19 Public Health Emergency (“COVID-19 PHE”) declared by the Secretary (the “Secretary”) of the Department of Health and Human Services (HHS) on January 31, 2020, pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C. 247), DEA used its authority under 21 U.S.C. 802(54)(D) to grant temporary exceptions to the

Ryan Haight Act

and its implementing regulations, allowing authorized practitioners to generally prescribe controlled substances in Schedules II-V through telemedicine.

Three years later, in March 2023, DEA, in concert with HHS, promulgated two notices of proposed rulemakings (NPRMs) (the “General Telemedicine NPRM,” and “Buprenorphine NPRM”) pursuant to 21 U.S.C. 802(54)(G), which collectively proposed to expand patient access to prescriptions via telemedicine relative to the pre-COVID-19 PHE landscape. On May 10, 2023, to prevent a lapse of care with the expiration of the COVID-19 PHE, DEA, jointly with HHS, promulgated a rule (the “First Temporary Rule”) pursuant to 21 U.S.C.802(54)(G) to extend the temporary exceptions originally authorized under the COVID-19 PHE through November 11, 2023.

On September 12 and 13, 2023, DEA hosted live, in-person Telemedicine Listening Sessions to receive additional input concerning the

practice of telemedicine

with regards to controlled substances and potential safeguards that could effectively prevent and detect diversion of controlled substances prescribed via telemedicine. DEA invited the public to express their views concerning the advisability of permitting telemedicine prescribing of certain controlled substances without any in-person medical evaluation at all, the availability and types of data that would be useful in detecting diversion of controlled substances via telemedicine, and specific additional safeguards that could be placed around the prescribing of Schedule II controlled substances via telemedicine.

On October 10, 2023, in light of the need to further evaluate the best course of action given the comments received in response to the March 2023 NPRMs and the presentations at the September 2023 Telemedicine Listening Sessions, DEA, jointly with HHS, issued a second temporary rule (the “Second Temporary Rule”) to further extend the temporary exceptions originally authorized under the COVID-19 PHE through December 31, 2024. On November 19, 2024, DEA and HHS issued a third temporary rule (the “Third Temporary Rule”) to again extend the temporary exceptions originally authorized under the COVID-19 PHE through December 31, 2025, to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled substance prescriptions.

The Third Temporary Rule has also provided additional time for DEA to promulgate the

Special Registration

regulations proposed in this NPRM, and additional time for practitioners to come into compliance with any new standards or safeguards eventually found within a final rule establishing a

Special Registration

framework. DEA has determined that the best course of action to ensure patient access to care, while maintaining sufficient safeguards to prevent and detect diversion of controlled substances, is to establish and maintain a regulatory scheme including three separate

Special Registrations

pursuant to 21 U.S.C. 802(54)(E) and 21 U.S.C. 831(h).

These separate

Special Registrations

would allow more comprehensive prescribing, including prescribing of Schedule II and narcotic and non-narcotic controlled substances in limited circumstances, by properly registered physicians and

mid-level practitioners

(hereinafter collectively referred to as

clinician practitioners

), and dispensing by online telemedicine platforms that constitute

covered online telemedicine platforms,

in their capacity as

platform practitioners,

who have proven to have a legitimate need for such

Special Registrations

and where DEA has concluded that such registration is consistent with the public interest. Once properly registered under the

Special Registration

framework,

clinician practitioners

would be considered

clinician special registrants

and

covered online telemedicine platforms,

in their capacity as

platform practitioners,

would be considered

platform special registrants.

This NPRM introduces the three types of

Special Registrations for Telemedicine:

(1) a

Telemedicine Prescribing Registration,

authorizing qualified

clinician practitioners

to prescribe Schedule III-V controlled substances via telemedicine, (2) an

Advanced Telemedicine Prescribing Registration,

authorizing qualified, specialized

clinician practitioners

(

e.g.,

psychiatrists,

hospice care

physicians) to prescribe Schedule II-V controlled substances via telemedicine, and (3) a

Telemedicine Platform Registration,

authorizing

covered online telemedicine platforms,

in their capacity as

platform practitioners,

to dispense Schedule II-V controlled substances.

To satisfy the

statutory requirements under 21 U.S.C. 831(h), DEA would also require the

special registrant

to maintain a

State Telemedicine Registration

for every state in which a patient is treated by the

special registrant,

unless otherwise exempted. The

State Telemedicine Registration

would be issued by DEA, not the states, and operate as an ancillary credential, contingent on the

Special Registration

held by the

special registrant.

The term “institutional practitioner” is currently defined at 21 CFR 1300.01. Proposed changes to 21 CFR 1300.01 will explicitly exclude

“covered online telemedicine platform” to clarify that such an entity is not an “institutional practitioner.”

To streamline the

Special Registration

application process, the NPRM would introduce a new registration application form, known as Form 224S. The three types of

Special Registrations

(

Telemedicine Prescribing Registration, Advanced Telemedicine Prescribing Registration,

and

Telemedicine Platform Registration

) and the

State Telemedicine Registration

(one type for

clinician special registrants

and one type for

platform special registrants

) would be on a three-year cycle. The NPRM also proposes heightened prescription requirements addressing the manner in which

special registration prescriptions

are issued, as well as additional elements required to be on a

special registration prescription

issued under a

Special Registration.

Special registration prescriptions

issued under the

Special Registration

would be required to be prescribed through electronic prescribing for controlled substances (EPCS), and after the

special registrant

has verified the identity of the patient and carried out a nationwide Prescription Drug Monitoring Program (PDMP) check of all 50 states and any U.S. district or territory that maintains its own PDMP (referred to as the “nationwide PDMP check”). The nationwide PDMP check requirement, however, would have a delayed effective date of three years. In the interim, for all Schedule II-V controlled substances,

clinician special registrants

would be required to conduct a PDMP check of: (1) the state/territory where the patient is located; (2) the state/territory where the

clinician special registrant

is located; and (3) any state/territory that has a PDMP reciprocity agreement with the states/territories where the patient and

clinician special registrant

are located.

Furthermore,

special registration prescriptions

would require the inclusion of the

Special Registration

numbers of the

clinician special registrant

and the

platform special registrant

(if a

platform special registrant

facilitated the prescription), and the

State Telemedicine Registration

numbers of the

clinician special registrant

and

platform special registrant

(if a

platform special registrant

facilitated the prescription). To ensure clarity and easy identification of the type of registration,

Special Registration

numbers and

State Telemedicine Registration

numbers would be formatted distinctly. This would allow registrants and DEA to differentiate them from each other and from conventional DEA registration numbers issued under 21 U.S.C. 823(g). Additionally, pharmacies filling

special registration prescriptions

would be able to easily verify these registration numbers to confirm that the prescribing

clinician practitioner

is authorized to prescribe controlled substances within a given Schedule via a

Special Registration,

and that a

platform practitioner,

if one facilitated the

special registration prescription,

is authorized to dispense controlled substances under the

Special Registration

framework.

It is also important to note when the proposed regulations would not apply. The

Ryan Haight Act,

and the telemedicine regulations implementing it thereunder, apply only in limited circumstances, impacting only a subset of practitioner-patient relationships: those where the prescribing practitioner intends to prescribe controlled substances, and has never conducted an in-person medical evaluation of the patient prior to the issuance of the prescription. In other words, the regulations implemented under the

Ryan Haight Act

would not be applicable to practitioner-patient relationships in which there has ever been a prior in-person medical evaluation of the patient by the practitioner.

Moreover, the regulations proposed in this rule are further limited to telemedicine practiced under a

Special Registration,

but would not apply to the other forms of the

practice of telemedicine

authorized under the

Ryan Haight Act.

The proposed regulations within this NPRM would not apply to the

practice of telemedicine

authorized under 21 U.S.C. 802(54)(A)-(D), (F), and (G). Therefore, these proposed regulations would not apply to the

practice of telemedicine

authorized under the

Expansion of Buprenorphine Treatment via Telemedicine Encounter

final rule (RIN 1117-AB78) or the

Continuity of Care via Telemedicine for Veterans Affairs Patients

final rule (RIN 1117-AB88) published elsewhere in this issue of the

Federal Register

. Under the authority of 21 U.S.C. 802(54)(G), these final rules permit, in limited circumstances, certain prescribing practitioners to issue prescriptions for controlled substances by telemedicine, without having personally performed an in-person medical evaluation or fulfilling the

Special Registration

requirements as proposed within this rule. At this stage, DEA remains committed to actively soliciting and considering feedback from the public and revising the

Special Registration

regulations as necessary and appropriate.

21 U.S.C. 802(54)(E).

See

Appendix A for Chart:

Do I Need a Special Registration for Telemedicine?

II. Legal Authority and Background

DEA implements and enforces the CSA and the

Controlled Substances Import and Export Act,

(21 U.S.C. 801-971), as amended. DEA publishes the implementing regulations for these statutes in 21 CFR parts 1300 to end. These regulations are designed to ensure a sufficient supply of controlled substances for medical, scientific, and other legitimate purposes, and to deter the diversion of controlled substances for illicit purposes. As mandated by the CSA, DEA establishes and maintains a closed system of control for manufacturing, distribution, and dispensing of controlled substances, and requires any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances to register with DEA, unless they meet an exemption, pursuant to 21 U.S.C. 822.

The CSA further authorizes the Attorney General (and the Administrator by delegation through 28 CFR part 0) to promulgate regulations necessary and appropriate to execute the functions of subchapter I (Control and Enforcement) and subchapter II (Import and Export) of the CSA.

“Dispense” in the context of this rulemaking means to deliver a controlled substance to an ultimate user, which includes the prescribing of a controlled substance. 21 U.S.C 802(10).

21 U.S.C. 871(b), 958(f).

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008.

The

Ryan Haight Act

amended the CSA by, among other things, adding several new provisions to prevent the illegal distribution and dispensing of controlled substances by means of the

internet.

A central feature of the

Ryan Haight Act

is the in-person medical evaluation requirement. The in-person medical evaluation requirement is set forth in 21 U.S.C. 829(e), which provides that “[n]o controlled substance that is a prescription drug as determined under the Federal Food, Drug, and

Cosmetic Act may be . . . dispensed by means of the internet without a valid prescription,”

and which defines “valid prescription” as “a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by . . . a practitioner who has conducted at least 1 in-person medical evaluation of the patient.”

Section 829(e), however, provides an exception to this in-person medical evaluation requirement where the practitioner is “engaged in the practice of telemedicine.”

21 U.S.C. 829(e)(1).

Id.

at 829(e)(2)(A)(i). Under the Ryan Haight Act, the requirement of an in-person medical evaluation does not apply to a “covering practitioner,”

id.

829(e)(2)(A)(ii), as defined by 829(e)(2)(C). A prescribing practitioner meeting this definition need not conduct an in-person medical evaluation as a prerequisite to prescribing a controlled substance to a given patient, provided that the practitioner for whom the practitioner is covering has provided an in-person medical evaluation of that patient and provided further that this covering arrangement is taking place on only a temporary basis. In addition, the covering practitioner—as with all practitioners who prescribe controlled substances—remains subject to the requirement that such prescriptions may be issued only for a legitimate medical purpose in the usual course of professional practice.

Id.

829(e)(3)(A).

Pursuant to 21 U.S.C. 802(54) the

practice of telemedicine

means “the practice of medicine in accordance with applicable Federal and state laws by a practitioner (other than a pharmacist)

who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system

referred to in section 1395m(m) of Title 42,” and which also falls within one of seven distinct categories that Congress determined were appropriate to allow for the prescribing of controlled substances via telemedicine despite the practitioner never having conducted an in-person medical evaluation of the patient.

While this statutory definition of the

practice of telemedicine

explicitly excludes pharmacists, such exclusion does not apply to situations where a pharmacist is acting in their capacity as a

mid-level practitioner,

authorized to dispense controlled substances in accordance with their state licensure.

42 U.S.C. 1395m(m) references, but does not define, such

telecommunications systems.

The Center for Medicare and Medicaid Services (CMS) promulgated regulations implementing these statutory provisions and define the term

interactive telecommunications system.

42 CFR 410.78(a)(3) defines

interactive telecommunications system

as “. . . [the] multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner. For services furnished

for purposes of diagnosis, evaluation, or treatment of a mental health disorder to a patient

in their home, interactive telecommunications

may include two-way, real-time audio-only communication technology

if the distant site physician or practitioner is technically capable to use an interactive telecommunications system as defined in the previous sentence, but the patient is not capable of, or does not consent to, the use of video technology” (emphases added). Though DEA's proposed regulatory definition for

audio-video telecommunications system

largely aligns with CMS's definition of

interactive telecommunications system,

DEA's proposed regulations would not authorize the use of audio-only communication technology for the diagnosis, evaluation, or treatment of mental health disorders, subject to one exception for opioid use disorder discussed in more depth later. These provisions reflect the heightened risks associated with prescribing controlled substances specifically.

The seven distinct categories provided under the statutory definition of the

practice of telemedicine

generally involve either circumstances in which an in-person medical evaluation has been rendered impracticable due to temporary emergencies, or circumstances in which the prescribing practitioner might be unable to satisfy the

Ryan Haight Act's

in-person medical evaluation requirement, yet nonetheless has sufficient medical information to prescribe a controlled substance for a legitimate medical purpose in the usual course of professional practice. In these circumstances, provided certain safeguards are in place to ensure that the practitioner who is engaged in the

practice of telemedicine

is able to conduct a

bona fide

medical evaluation of the patient at the remote location, and is otherwise acting in the usual course of professional practice, the

Ryan Haight Act

contemplates that the practitioner will be permitted to prescribe controlled substances by means of the

internet

despite not having conducted an in-person medical evaluation. The

Ryan Haight Act

defines these categories through the definition of “practice of telemedicine,” which is set forth in 21 U.S.C. 802(54).

As a general matter, those seven distinct categories include telemedicine encounters where: (1) a patient is physically located at a DEA-registered hospital or clinics, and the remote prescribing practitioner is DEA-registered in the state in which the patient is located; (2) a patient is being treated by a prescribing practitioner, and in the physical presence of a DEA-registered practitioner in the state in which the patient is located; (3) the prescribing practitioner is an employee or contractor of the Indian Health Service (IHS), acting within the scope of the practitioner's employment, who has been designated an

internet Eligible Controlled Substances Provider

by HHS; (4) it takes place during a public health emergency declared by HHS under section 247d of title 42; (5) the practitioner has obtained a

Special Registration

with DEA;

(6) there is a medical emergency that prevents the patient from being in the physical presence of an employee or contractor of the Veterans Health Administration (VHA) and one of its hospitals or clinics, and immediate intervention by the practitioner using controlled substances is required to prevent injury or death; and (7) any other circumstances that DEA and HHS have jointly determined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety.

Congress enacted legislation in addition to the

Ryan Haight Act

which required DEA to “promulgate final regulations specifying . . . the limited circumstances in which a special registration for telemedicine may be issued.” 21 U.S.C. 831(h)(2). In particular, the SUPPORT for Patients and Communities Act (“SUPPORT Act”), signed into law on October 24, 2018, mandated that, in consultation with the Secretary [of Health and Human Services], the Attorney General shall promulgate final regulations specifying—(A) the limited circumstances in which a special registration for telemedicine . . . may be issued; and (B) the procedure for obtaining [a] special registration for telemedicine.”

Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act

(SUPPORT Act), Public Law 115-271, 3232, 132 Stat. 3894, 3950 (2018). The Attorney General has delegated this authority to the Administrator of DEA.

See

28 CFR 0.100. As required by the SUPPORT Act, DEA has consulted with representatives of the Secretary of Health and Human Services regarding the substance of this proposed rule.

21 U.S.C. 802(54).

As noted above, the

Ryan Haight Act,

and the telemedicine regulations implementing it thereunder, apply only in limited circumstances, impacting only a subset of practitioner-patient relationships: where the prescribing practitioner wishes to prescribe controlled substances and has never conducted an in-person medical evaluation of the patient prior to the issuance of the prescription. In other words, the regulations proposed in this rule would not be applicable to practitioner-patient relationships in which there has been a prior in-person medical evaluation of the patient by the practitioner.

COVID-19 Public Health Emergency.

In response to the COVID-19 PHE, as declared by the Secretary on January 31, 2020, pursuant to the authority under section 319 of the

Public Health Service Act

(42 U.S.C. 247), DEA granted temporary exceptions to the

Ryan Haight Act

and DEA's implementing regulations under 21 U.S.C. 802(54)(D), one of the seven distinct categories of telemedicine envisioned under the statutory definition of the

practice of telemedicine.

In order to prevent lapses in care, these exceptions allowed for the prescribing of controlled substances via

telemedicine encounters even when the prescribing practitioner had not conducted an in-person medical evaluation of the patient. These telemedicine flexibilities authorized practitioners to prescribe Schedule II-V controlled substances via audio-video telemedicine encounters, including Schedule III-V opioid controlled substances approved by the Food and Drug Administration (FDA) for maintenance and withdrawal management treatment of opioid use disorder via audio-only telemedicine encounters, provided that such prescriptions otherwise comply with the recommendations outlined in DEA guidance documents, the requirements outlined in DEA regulations, and applicable Federal and State law. DEA granted those temporary exceptions to the

Ryan Haight Act

and DEA's implementing regulations via two letters published in March 2020:

• A March 25, 2020 “Dear Registrant” letter signed by William T. McDermott, DEA's then-Assistant Administrator, Diversion Control Division (the McDermott Letter);

and

William T. McDermott, DEA Dear Registrant letter, Drug Enforcement Administration (March 25, 2020),

https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-018)(DEA067)%20DEA%20state%20reciprocity%20(final)(Signed).pdf.

• A March 31, 2020 “Dear Registrant” letter signed by Thomas W. Prevoznik, DEA's then-Deputy Assistant Administrator, Diversion Control Division (the Prevoznik Letter).

Thomas W. Prevoznik, DEA Dear Registrant letter, Drug Enforcement Administration (March 31, 2020),

https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-022)(DEA068)%20DEA%20SAMHSA%20buprenorphine%20telemedicine%20%20(Final)%20+Esign.pdf.

Prior NPRMs and Temporary Rules; Telemedicine Listening Sessions.

On March 1, 2023, DEA, in concert with HHS and pursuant to 21 U.S.C. 802(54)(G), promulgated two NPRMs in the

Federal Register

Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation

(the “General Telemedicine NPRM”)

and

Expansion of Induction of Buprenorphine via Telemedicine Encounter

(the “Buprenorphine NPRM”),

which proposed to expand patient access to prescriptions for controlled substances via telemedicine encounters relative to the pre-COVID-19 PHE landscape. The purpose of the two proposed rules was to make permanent some of the telemedicine flexibilities established during the COVID-19 PHE in order to facilitate patient access to controlled substance medications via telemedicine when consistent with public health and safety, while maintaining effective controls against diversion. The comment period for these two NPRMs closed on March 31, 2023. Those NPRMs generated a total of 38,369 public comments—35,454 comments on the General Telemedicine NPRM and 2,915 comments on the Buprenorphine NPRM.

88 FR 12875 (Mar. 1, 2023).

88 FR 12890 (Mar. 1, 2023).

On May 10, 2023 DEA, jointly with HHS (with the Substance Abuse and Mental Health Services Administration (SAMHSA) acting on behalf of HHS), issued the First Temporary Rule pursuant to 21 U.S.C. 802(54)(G), which extended the full set of telemedicine flexibilities regarding the prescribing of controlled substances, as had been in place under the COVID-19 PHE, through November 11, 2023.

The First Temporary Rule also provided a one-year grace period, through November 11, 2024, to any practitioner-patient telemedicine relationships that had been or would be established on or before November 11, 2023.

Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 88 FR 30037 (May 10, 2023).

On September 12 and 13, 2023, DEA hosted the live, in-person Telemedicine Listening Sessions, to receive additional input concerning the practice of telemedicine with regards to prescribing controlled substances and potential safeguards that could effectively prevent and detect diversion of controlled substances prescribed via telemedicine. DEA invited the public to express their views concerning the advisability of permitting telemedicine prescribing of certain controlled substances without any in-person medical evaluation at all, the availability and types of data that would be useful in detecting diversion of controlled substances via telemedicine that are either already reported or could be reported, and specific additional safeguards that could be placed around the prescribing of Schedule II controlled substances via telemedicine. Approximately 58 stakeholders, including

institutional practitioners

and

clinician practitioners,

pharmacists, trade associations, state agencies, and other public interest groups, presented at the listening sessions.

On October 10, 2023, in light of the need to further evaluate the best course of action given the comments received in response to the March 2023 NPRMs and the presentations at the Telemedicine Listening Sessions, DEA, jointly with HHS, issued the Second Temporary Rule, also pursuant to 21 U.S.C. 802(54)(G), thereby extending the full set of telemedicine flexibilities regarding prescription of controlled substances as were in place during the COVID-19 PHE through December 31, 2024.

The extension authorized all DEA-registered practitioners to prescribe Schedule II-V controlled substances via telemedicine through December 31, 2024, whether or not the patient and practitioner established a telemedicine relationship on or before November 11, 2023. In other words, the grace period provided in the First Temporary Rule was effectively subsumed by this Second Temporary Rule, which continued the extension of the current flexibilities for all practitioner-patient relationships—not just those established on or before November 11, 2023—until the end of 2024. The purpose of the Second Temporary Rule, like the one before it, was to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled substance prescriptions, as well as to allow adequate time for providers to come into compliance with any new standards or safeguards that are promulgated as part of a final set of telemedicine regulations.

Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, 88 FR 69879 (October 10, 2023).

Tribal Consultations.

On June 13 and 27, 2024, the Office of Tribal Justice, Department of Justice (OTJ) collaborated with DEA to host two virtual DOJ Government-to-Government Tribal Consultations to seek input from Tribal governments on the practice of telemedicine within American Indian/Alaskan Native (AI/AN) communities. OTJ and DEA invited the Tribal leaders of all federally recognized Tribes using the Bureau of Indian Affairs Tribal Leaders Directory, and provided a framing paper detailing the flexibilities, public engagement, and regulatory actions taken by DEA in recent years concerning telemedicine. OTJ and DEA invited Tribal input on any question or topic of interest related to the use of telemedicine by AI/AN communities, and specifically requested input on potential regulatory requirements and suggestions on what would help Tribal governments implement and comply with a future rule. OTJ and DEA also welcomed the submission of any written comments as well.

III. Need for Further Rulemaking: Special Registration for Telemedicine

In the process of reviewing and evaluating the comments to the

proposed 2023 General Telemedicine NPRM and Buprenorphine NPRM, as well as the presentations made by various stakeholders at the Telemedicine Listening Sessions, DEA has determined that the best course of action to ensure patient access to care, while maintaining sufficient safeguards to detect and protect against the diversion of controlled substances, is to establish and maintain a separate

Special Registration for Telemedicine

(also referred to as simply “Special Registration”),

i.e.,

the regulatory scheme Congress specifically authorized in 21 U.S.C. 802(54)(E) and 21 U.S.C. 831(h). As compared to the pre-COVID-19 PHE landscape, the

Special Registration

proposed herein would allow more comprehensive prescribing, including prescribing of Schedule II narcotics and non-narcotic controlled substances in limited circumstances, by properly registered

clinician practitioners

and dispensing by

platform practitioners

with a legitimate need for the

Special Registration.

In determining when a

Special Registration

should be issued under 21 U.S.C. 802(54)(E), DEA must consider the criteria set forth in 21 U.S.C. 831(h). First, DEA must evaluate a practitioner's legitimate need for such a

Special Registration,

as well as clearly define the limited circumstances under which a

Special Registration

is appropriate.

These statutory requirements emphasize the need for careful consideration when extending prescribing privileges through telemedicine. This evaluation is crucial in determining whether telemedicine serves a necessary role, especially given the heightened risks of diversion and inappropriate prescribing of controlled substances posed by remote services where a patient has never undergone an in-person medical evaluation with the prescribing practitioner.

21 U.S.C. 831(h)(1)(A).

While the COVID-19 PHE created a genuine need for increased use of telemedicine, it also highlighted the inherent risks associated with remote prescribing, particularly in the absence of in-person medical evaluations. In a 2021

Harris Poll

online survey conducted on behalf of

Quest Diagnostics,

67 percent of physicians expressed concerns about missing signs of drug use or use disorders during the COVID-19 PHE, and 75 percent of physicians felt that telemedicine constrained their ability to assess whether patients were at risk of, or already, misusing prescription drugs.

Although the telemedicine flexibilities during the PHE allowing practitioners to prescribe controlled substances without prior in-person medical evaluations were necessary to prevent lapses of care amid a global pandemic, it also facilitated the emergence of concerning business models engaged in the widespread diversion of controlled substances, taking advantage of the flexibilities established during the COVID-19 PHE.

Majority of Physicians Worry Signs of Addiction Were Missed During Pandemic, Finds New Quest Diagnostics Health Trends Report,

Quest Diagnostics (Nov. 15, 2021),

https://newsroom.questdiagnostics.com/2021-11-15-Majority-of-Physicians-Worry-Signs-of-Addiction-Were-Missed-During-Pandemic,-Finds-New-Quest-Diagnostics-Health-Trends-R-Report#assets_30649_137302-130:199.

While a survey conducted on behalf of a diagnostics services company, such as

Quest Diagnostics,

may carry the potential for bias—given the company's potential preference for traditional in-person healthcare models—it still offers valuable insights, even if interpreted with some caution. When considered in context, such information still provides a unique data point, that when weighted accordingly, can inform this analysis. The results of the

Harris Poll

survey are further reinforced by a 2024 National Center for Health Statistics (NCHS) Data Brief that shows the percentage of physicians who feel telemedicine

fully

provides the same care as in-person is 4.0 percent for primary care, 6.3 percent for surgical specialty, and 6.0 percent for medical specialty. Myrick K, Mahar M, DeFrances CJ.

Telemedicine Use Among Physicians by Physician Specialty: United States, 2021. NCHS Data Brief,

no 493. (Feb. 2024),

https://www.cdc.gov/nchs/data/databriefs/db493.pdf.

In June 2024, the founder and clinical president of a telehealth company were arrested for allegedly participating in a scheme to distribute

Adderall

and other stimulants online and conspiring to commit healthcare fraud. Specifically, they have been accused of arranging the prescription of over 40 million pills of

Adderall

and other stimulants, often with no legitimate medical purpose. The company allegedly provided easy access to controlled substances in exchange for a monthly subscription fee, leading to tragic consequences, including overdoses and deaths. These allegations underscore DEA's need to judiciously evaluate when a practitioner has a legitimate need for a

Special Registration,

and to ensure that any rule permanently authorizing telemedicine contains sufficient safeguards.

Founder/CEO and Clinical President of Digital Health Company Arrested for $100M Adderall Distribution and Health Care Fraud Scheme,

U.S. Department of Justice, Press Release Number: 24-752 (June 13, 2024),

https://www.justice.gov/opa/pr/founderceo-and-clinical-president-digital-health-company-arrested-100m-adderall-distribution.

Second, DEA may only issue a

Special Registration

if the practitioner is “registered under 21 U.S.C. 823(g) in the state which the patient will be located” when receiving the telemedicine treatment, unless the

practitioner

is excepted from 823(g) registration.

Such 823(g) registration in the patient's state is a critical validation of the practitioner's qualifications and expertise in prescribing controlled substances within a given state. Moreover, the definition of “practice of telemedicine” under the

Ryan Haight Act

requires the practitioner to engage in the practice of medicine only “in accordance with applicable Federal and state laws.” A

special registrant

under this proposed framework would need to continue to comply with the laws and regulations of the state in which registered, and the laws and regulations of the state in which they are issuing

special registration prescriptions

via a telemedicine encounter. Thus, where one state's law and regulations are more restrictive than the other state's law and regulations, the

special registrant

would be required to follow the more restrictive state law and regulations.

21 U.S.C. 831(h)(1)(B).

Proposed 21 CFR 1300.04 defines a

special registration prescription

to mean “a prescription, defined under [21 CFR 1300.01], for controlled substances issued under a practitioner's Special Registration for Telemedicine for a legitimate medical purpose in the usual course of professional practice through the utilization of an audio-video telecommunications system defined in § 1300.04 of this chapter.

Under some circumstances, a special registrant may operate under a state reciprocity agreement or other form of state permission that would authorize the special registrant to comply only with the normally applicable law or regulations of either the state in which they are registered or the state in which they are practicing. In other words, states may deem compliance with one state's normally applicable law and regulations as compliance with both states' laws and regulations. In this context, DEA would understand the special registrant to be complying with both states' laws and regulations, because the special registrant's prescribing of controlled substances would be authorized by both states.

Third, in all instances,

clinician practitioners

“must establish and maintain a bonafide doctor-patient relationship in order to act `in the usual course of . . . professional practice' and to issue a prescription for a `legitimate medical purpose.' ”

The “usual course of professional practice” is defined by the state in which a registrant practices, because “[c]onsistent with the CSA's recognition of the State's primary role in regulating the practice of medicine, the [CSA] generally looks to State law and standards of medical practice to determine whether a doctor and patient have established (and are maintaining) a bonafide doctor-patient relationship” at the time of the prescription.

Dewey C. MacKay, 75 FR 49956, 49973 (2010), aff'd,

MacKay

DEA,

664 F.3d 808 (10th Cir. 2011).

Id.

Direct-to-Consumer Online Telemedicine Platforms.

In today's rapidly evolving healthcare landscape, third-party online telemedicine platforms play a large and integral role, as intermediaries, in the delivery of remote healthcare to patients beyond traditional medical settings, with a shift towards predominantly virtual interactions. Many of these online telemedicine platforms employ a direct-to-consumer (“DTC”) business model in which they introduce or connect

patients with a remote

clinician practitioner

enabling the patient to be “seen” anywhere using a computer or smart phone, forgoing the need for the patient to go to a medical facility to use the facility's telecommunications system.

Today's DTC online telemedicine platforms often engage in marketing to attract new patients, whom they then introduce or match with

clinician practitioners

under the platforms' direct employment or contract. The payment arrangements between the patient and the platform vary, but some platforms offer subscriptions, where patients pay a monthly fee for virtual consultations, sometimes up to and including an unlimited number of consultations, with a

clinician practitioner.

Often, but not always, the online telemedicine platform may own and operate the virtual environment, including the telecommunications system, where the patient and practitioner virtually “meet,” providing the technological infrastructure or support. Unlike traditional medical settings, the

clinician practitioner

conducts the medical evaluation remotely, after which they may prescribe medications, including controlled substances. While the DTC online telemedicine platforms are not entirely new, they proliferated in recent years, in large part due to the COVID-19 pandemic.

Dispensing by Practitioners under the CSA.

Although these third-party, DTC online telemedicine platforms do not directly prescribe to patients or physically dispense controlled substances to patients, certain platforms' central involvement as intermediaries in the remote dispensing of controlled substances qualifies them as “practitioners” engaged in “dispensing” under the CSA. Under the CSA, to “dispense” means “to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance.”

This statutory definition encompasses not only the physical act of handing out medications, but the broader process of providing them to patients under the direction of a licensed healthcare provider.

21 U.S.C. 802(10).

The online telemedicine platforms serving as intermediaries for the prescribing of controlled substances fall squarely within the CSA's broad definition of “practitioner.” Under the CSA a “practitioner” means “a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.”

According to this statutory definition, a “practitioner” is not limited solely to individual healthcare providers, but also encompasses entities permitted by law to distribute or dispense controlled substances. Furthermore, considering the evolving nature of healthcare delivery, recognizing certain DTC online telemedicine platforms as practitioners engaged in dispensing under the CSA reflects the current landscape of telemedicine practice and ensures that DEA's regulations remain relevant and responsive to changes in healthcare technology.

Public Law 91-513 and 21 U.S.C. 802(21). The definition of

practitioner

has also remained unchanged since the enactment of the original CSA.

See

Senate Report 110-521,

Ryan Haight Online Pharmacy Consumer Protection Act of 2007,

accompanying S.980, November 17, 2008 (providing “[c]ertain telemedicine practices are exempted from the in-person medical evaluation requirement. The Committee recognizes that telemedicine is a practice tool that can improve health outcomes and reduce costs. It is not the intent of the Committee to restrict the legitimate practice of telemedicine or the emerging practices of telemedicine which are consistent with medical practice guidelines of the State in which the practitioner is licensed, provided such practices do not contravene the goal of effectively controlling the diversion of controlled substances”).

DEA Registration of Intermediaries.

The registration of telemedicine intermediaries is not a novel concept. In fact, when Congress amended the CSA with the

Ryan Haight Act,

it recognized the integral role telepresenters, serving as intermediaries, played in certain telemedicine models. In 21 U.S.C. 802(54)(A)-(B), Congress specifically authorized two categories of telemedicine, both involving an intermediary healthcare provider facilitating a medical evaluation between a patient and a

clinician practitioner

located at a distance. Such intermediaries, in this context, are referred to as telepresenters. To uphold the integrity of the closed system, Congress required that such telepresenters, as intermediaries, be registered with DEA. Registration, the cornerstone of the closed system, helps to ensure that such intermediaries are qualified and accountable to DEA, reducing the risk of vulnerabilities or loopholes in this closed system that could lead to diversion and abuse of controlled substances.

In addition to these two telepresenter categories, Congress created two additional regulatory categories (the

special registration

category and the joint rule category) to allow DEA to carry out its diversion control mission in light of future industry developments.

See

Senate Report 110-521,

Ryan Haight Online Pharmacy Consumer Protection Act of 2007,

accompanying S.980, November 17, 2008 (noting that the statute provides that the Attorney General and the Secretary of Health and Human Services may promulgate regulations that allow for the full practice of telemedicine consistent with medical practice guidelines, so long as these regulations continue to effectively control diversion).

Special Registration of Certain DTC Online Telemedicine Platforms.

Certain modern DTC online telemedicine platforms of today, which play a substantial and integral role as intermediaries in the remote dispensing of controlled substances, also require registration with DEA. These platforms are indispensable for delivering telemedicine services directly to patients through virtual platforms, in contrast to the other telemedicine models such as those that utilize telepresenters under 21 U.S.C. 802(54)(A)-(B). The necessity for oversight of these newer telemedicine intermediaries is heightened by concerns arising from business practices that have come to light during and after the COVID-19 pandemic. These practices include platforms that incentivize the prescription of controlled substances to patients by practitioners and the exertion of control over the medications prescribed to patients. DEA has been informed by some clinicians that there have been instances when they terminated their relationship with an online telemedicine platform and, in doing so, forfeited access to their patient's medical records stored by the platform. This renders such records non-compliant with DEA regulations, which mandate that the records be readily retrievable by the practitioner, because they become entirely inaccessible to the

clinician practitioner.

As discussed in further detail below, DEA is proposing the

Special Registration

of these DTC online telemedicine platforms when they meet the proposed regulatory definition of a

covered online telemedicine platform.

DEA is proposing a definition for

covered online telemedicine platform,

delineating the criteria that indicate their substantial and integral role as intermediaries in the remote dispensing of controlled substances, qualifying them as practitioners engaged in dispensing under the CSA and subject to the requirements imposed upon non-

pharmacist practitioners

under the

Controlled Substances Act

and its regulations.

See supra

footnote 15.

When any one of the four outlined factors are present, it solidifies the platform's role as an integral intermediary in the remote dispensing of controlled substances.

The proposed definition and criteria are intended to provide a practical and clear framework for identifying when a DTC online telemedicine platform's conduct qualifies them as a

covered online telemedicine platform,

mandating registration as a dispenser with DEA.

As proposed, this definition is intended to limit the

Special Registration

requirements only to those DTC online telemedicine platforms that play a substantial and integral role as intermediaries in the remote dispensing of controlled substances.

The behaviors listed in these four factors are included solely to determine whether a platform is serving as an integral intermediary. Federal, state, or local laws and/or regulations may impose statutory or regulatory requirements related to these behaviors. The inclusion of these behaviors in the definition of

covered online telemedicine platform

does not indicate that such behaviors are permitted under any particular law or regulation.

The definition of

covered online telemedicine platform

and the four criteria are discussed in further detail below in the NPRM's discussion of proposed regulatory definitions.

The definition of

covered online telemedicine platform

also explicitly excludes certain types of entities, including hospitals, clinics, insurance providers, and

local in-person medical practices. Local in-person medical practice

is, in turn, defined by this rule to be a medical practice where all its offices are within 100 miles of each other, and where less than 50 percent of the total prescriptions for controlled substances collectively issued by the practice's physicians and

mid-level practitioners

are issued via telemedicine in any given calendar month, but is not a hospital, clinic, or insurance provider. The type of entities excluded from the definition of

covered online telemedicine platform

are entities that engage in conduct that could potentially fall under the definition's criteria but are not the types of entities whose primary business operations rely on, or center around, telemedicine services. Moreover, it should be noted that the proposed definition of

local in-person medical practice

uses the term “telemedicine” rather than “

practice of telemedicine.

” This distinction is significant, as “telemedicine” is used in its general, colloquial sense, whereas the “

practice of telemedicine

” carries the specific statutory meaning defined by the

Ryan Haight Act.

Determining whether an entity dispenses controlled substances and meets the criteria of a

covered online telemedicine platform

is a fact-specific inquiry. If there is any uncertainty regarding the entity's role as a dispenser, particularly concerning its involvement in the practitioner-patient relationship, registering may be advisable to avert the risk of enforcement action based on potential unregistered, and thus illegal, dispensing of controlled substances.

IV. Section-by-Section Discussion of Proposed Rule

The proposed regulations discussed below are designed to satisfy the statutory mandates of 21 U.S.C. 831(h) and 21 U.S.C. 802(54)(E), while fulfilling DEA's core responsibilities of regulating controlled substances and adapting to the evolving landscape of telemedicine, including the rise of new types of DTC online telemedicine platforms engaged in dispensing of controlled substances. Before discussing the proposed regulations, it is important to once again highlight what they do not govern or permit. First, as emphasized previously, the proposed regulations do not affect practitioner-patient relationships in cases where an in-person medical evaluation has occurred at any point within the relationship. Once an in-person medical evaluation has taken place, the practitioner-patient relationship falls outside the scope of the

Ryan Haight Act

and the DEA regulations implementing the

Ryan Haight Act.

Second, these proposed regulations primarily focus on the

practice of telemedicine

under the

Special Registration

framework authorized by the

Ryan Haight Act.

Other categories of telemedicine established by the

Ryan Haight Act,

such as telemedicine occurring during a public health emergency declared by HHS as authorized under 21 U.S.C. 802(54)(D), are not subject to the registration, prescription, and recordkeeping and reporting regulations proposed in this NPRM.

Ryan Haight Online Pharmacy Consumer Protection Act of 2008,

Public Law 110-425, 122 Stat. 4820, § 3(a) (2008) (codified as amended in 21 U.S.C. 802(54)(E)).

Third, these proposed regulations would not apply in the absence of a prescription for controlled substances.

In other words, practitioners would

not

be required to obtain a

Special Registration

unless they wish to prescribe or otherwise dispense controlled substances to patients via telemedicine encounters. And fourth, the proposed regulations would only permit the

prescribing

of controlled substances through telemedicine by

clinician practitioners.

Under the

Special Registration

framework,

clinician practitioners

would not be authorized to engage in other modes of “dispensing,” such as “administering” controlled substances to patients via telemedicine.

This is an important distinction given potential conflation between colloquial use of the term “telemedicine” and the statutory definition of the “practice of telemedicine” in the CSA and these proposed regulations. To illustrate this point, the following scenarios are non-exhaustive examples in which “telemedicine” may occur in the colloquial sense but would not constitute the “practice of telemedicine” under the CSA or these proposed regulations: (1) a practitioner issues a prescription for a non-controlled substance; (2) a practitioner treats the patient through audio-visual means and, after doing so, determines the patient does not require controlled substances; or (3) a practitioner is a mental health counselor who treats patients using “talk therapy” exclusively, without prescribing controlled substances.

21 U.S.C. 802(2) defines “administer” to mean the “direct application of a controlled substance to the body of a patient or research subject by a practitioner (or, in his presence, by his authorized agent), or the patient or research subject at the direction and in the presence of the practitioner, whether such application be by injection, inhalation, ingestion, or any other means.”

A. Registration Requirements Under 21 CFR Part 1301

As discussed earlier, registration is the cornerstone of the closed system of control for manufacturing, distribution, and dispensing of controlled substances, and requires any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances to register with DEA, unless otherwise exempted. Establishing a

Special Registration

for telemedicine would enhance patient access to care by allowing certain practitioners to prescribe controlled substances via telemedicine without the limitations of geographical barriers. At the same time, it would establish the appropriate circumstances and guardrails for telemedicine-based prescribing and dispensing of controlled substances where an in-person medical evaluation has never been performed by the prescribing practitioner. The rise of DTC online telemedicine platforms in recent years has further transformed healthcare delivery, but it has also introduced new challenges and heightened risks of diversion due to the remote nature of care delivery. The proposed registration requirements for telemedicine-based prescribing and dispensing create a new business activity within DEA's overarching registration framework, distinguishing it from the traditional modes of dispensing under a 21 U.S.C. 823(g) registration.

1. Three Types of Special Registration; Registrant Eligibility

The proposed requirements for the

Special Registration

are devised to meet the statutory requirements of 21 U.S.C. 831(h). This provision authorizes DEA to issue a

Special Registration

if the practitioner demonstrates a legitimate need for a

Special Registration.

Moreover, this statutory provision requires DEA to promulgate regulations specifying the limited circumstances under which a

Special Registration

may be issued and establish clear eligibility criteria for practitioners and the procedure for seeking a

Special Registration.

To accommodate the varying legitimate needs of practitioners, including both

clinician practitioners

and

covered online telemedicine platforms,

in their capacity as

platform practitioners,

the proposed framework offers three distinct categories of

Special Registrations.

Proposed 21 CFR 1301.11.

21 U.S.C. 831(h)(1)(A).

Id.;

831(h)(2)(A).

The first category, the

Telemedicine Prescribing Registration,

would authorize the prescribing of Schedules III through V controlled substances by

clinician practitioners.

The second category, the

Advanced Telemedicine Prescribing Registration,

would authorize certain specialized

clinician practitioners

the privilege to prescribe not only Schedule III through V controlled substances, but Schedule II controlled substances as well,

even though such substances have higher potential for abuse and dependence.

And lastly, the third category, the

Telemedicine Platform Registration,

would authorize

covered online telemedicine platforms

to dispense Schedules II through V controlled substances through a

clinician practitioner

possessing either a

Telemedicine Prescribing Registration

or an

Advanced Telemedicine Prescribing Registration.

Proposed 21 CFR 1301.11(c)(2).

Proposed 21 CFR 1301.11(c)(3).

See

21 U.S.C. 812(b)(2), (3).

Proposed 21 CFR 1301.11(c)(4).

Under proposed § 1301.11(c)(1)(A), an applicant for one of the three types of

Special Registration

would be required to already have one or more DEA registrations under 21 U.S.C. 823(g) to prescribe (if an

clinician practitioner

) or dispense (if a

platform practitioner

) controlled substances in a state in which they are licensed, registered, or otherwise permitted to prescribe or dispense controlled substances through telemedicine, unless they are otherwise exempted.

This requirement for

Special Registration

streamlines the review and approval process for applications for

Special Registrations

by building upon the checks and assessments already conducted for 21 U.S.C. 823(g) registrations. While the proposed framework allows for VA

practitioners

to seek and obtain a

Special Registration,

DEA and HHS have also jointly promulgated the

Continuity of Care via Telemedicine for Veterans Affairs Patients

final rule (RIN 1117-AB88), published elsewhere in this issue of the

Federal Register

, which specifically addresses the

practice of telemedicine

within the VA health care system. As discussed above, a DTC online telemedicine platform that qualifies as a

covered online telemedicine platform

dispenses controlled substances and must register with DEA in its capacity as a dispenser. It also bears emphasizing that proposed § 1301.11(c)(1) requires that

covered online telemedicine platforms,

like their

clinician practitioner

counterparts, already have one or more DEA registrations under 21 U.S.C. 823(g) to dispense controlled substances; DEA registrations under 21 U.S.C. 823(g) in turn require licensing of the activity by the state in which DEA registration under 21 U.S.C. 823(g) is sought.

Proposed § 1301.11(c)(1)(i) makes it clear that those officials for whom the requirement of registration to prescribe is generally waived under § 1301.23(a) of this chapter must still obtain a

Telemedicine Prescribing Registration

Advance Telemedicine Prescribing Registration

before issuing

special registration prescriptions.

Such officials are, as described below, exempt from obtaining

State Telemedicine Registrations,

though they must identify all the states in which patients will be treated via telemedicine on their registration application.

21 CFR 1301.23(a) waives the requirement of registration “for any official of the U.S. Army, Navy, Marine Corps, Air Force, Space Force, Coast Guard, Public Health Service, or Bureau of Prisons who is authorized to prescribe, dispense, or administer, but not to procure or purchase, controlled substances in the course of his/her official duties.”

a. Telemedicine Prescribing Registration (Schedules III-V) Clinician Practitioners Eligibility

To be eligible for the

Telemedicine Prescribing Registration

under proposed § 1301.11(c)(2),

clinician practitioners

would need to demonstrate that they have a legitimate need for a

Special Registration.

DEA has determined that physicians and board-certified

mid-level practitioners

(defined under 21 CFR 1300.01) have a legitimate need to prescribe Schedules III through V controlled substances when they anticipate that they will be treating patients for whom requiring in-person medical evaluations prior to prescribing Schedule III-V controlled substances could impose significant burdens on

bona fide

practitioner-patient relationships. For example, practitioners may have a legitimate need for the

Special Registration

when their patients face significant challenges in attending in-person medical evaluations, such as severe weather conditions, living in remote or distant areas, or having communicable diseases, which make in-person appointments difficult or even unadvisable.

b. Advanced Telemedicine Prescribing Registration (Schedules II-V) Clinician Practitioner Eligibility

To be eligible for the

Advanced Telemedicine Prescribing Registration

under proposed § 1301.11(c)(3), physicians and

mid-level practitioners,

clinician practitioners,

would not only need to demonstrate they have a legitimate need for the

Special Registration

but that such need warrants the authorization of prescribing of Schedule II controlled substances in addition to Schedules III through V controlled substances. DEA has determined that certain specialized physicians and board-certified

mid-level practitioners

have a legitimate need to prescribe Schedule II controlled substances via telemedicine when treating particularly vulnerable patient populations. Such authorization is reserved only for the most compelling use cases, ensuring that Schedule II prescribing via telemedicine is used only when necessary.

Consistent with these concerns regarding vulnerable patient populations, and cognizant of the high potential for abuse that exists for Schedule II controlled substances, DEA has determined that only certain specialized physicians and board-certified

mid-level practitioners

have a legitimate need for the

Advanced Telemedicine Prescribing Registration,

in the following limited circumstances or practice specialties:

(1) psychiatrists;

(2)

hospice care

physicians;

(3)

palliative care

physicians;

(4) physicians rendering treatment at

long term care facilities;

(5) pediatricians;

Proposed 21 CFR 1306.45(e) would also require that the parent or guardian of patients under the age of 18 be present in the room with the patients when the patients are being issued prescriptions for a Schedule II controlled substance.

(6) neurologists; and

(7)

mid-level practitioners

and physicians from other specialties who are board certified in the treatment of psychiatric or psychological disorders,

hospice care, palliative care,

pediatric care, or neurological disorders unrelated to the treatment and management of pain.

The type of specialized practitioners and board-certified

mid-level practitioners

eligible for the

Advanced Telemedicine Prescribing Registration

typically treat patients that face significant healthcare accessibility challenges, and, in some cases, who suffer from particularly debilitating or terminal illnesses. The hardships faced by such patients were discussed at length by certain speakers during the Telemedicine Listening Sessions. For example, some speakers discussed accessibility issues created by shortages of psychiatrists, and the need for qualified, perhaps board-certified, psychiatrists to diagnose and treat illnesses like ADHD.

Another group of speakers addressed the accessibility challenges faced by

palliative

and

hospice

patients, often homebound, who may need urgent pain treatment and symptom management.

The heightened specificity of these limited circumstances is intended to strike a balance between ensuring access to necessary medications for vulnerable patients while controlling the prescribing of Schedule II controlled substances that have a higher potential risk of abuse and dependence.

See

Telemedicine Listening Sessions, Georgia Gaveras (Talkiatry), 21:6-22:4, 25:1-8 (Sept. 12, 2023); John Heaphy (NY State Dep. of Health, Mental Health), 76:10-77:14 (Sept. 13, 2023); and Caitlin Gilloley (American Hospital Association), 63:21-64:14 (Sept. 13, 2023).

See

Telemedicine Listening Sessions, David Hoffman (Columbia University), 44:17-44:23, 45:16-21, 46:19-21 (Sept. 12, 2023); Robin Plumer, M.D., 190:18-191:17 (Sept. 12, 2013); Kevin Duane, PharmD, 206:16-207:1 (Sept. 12, 2023); Joseph Rotella, M.D. (American Academy of Hospice and Palliative Medicine), 289:25-290:12 (Sept. 12, 2023); Alex Armitage, M.D. (Baylor Scott & White Health), 43:8-14, 43:24-44:10 (Sept. 13, 2023); and Caitlin Gilloley (American Hospital Association), 63:21-64:14 (Sept. 13, 2023).

Furthermore, these eligible specialized physicians and board-certified

mid-level practitioners

are uniquely positioned to provide expert care for specific, vulnerable patient populations. These specialized physicians and

mid-level practitioners

have specialized training and in-depth knowledge to equip them to make informed decisions regarding the use of Schedule II controlled substances when prescribed remotely to particularly vulnerable patient groups. While DEA is not proposing regulations that delineate specific criteria for practitioners falling into the designated practice specialties,

clinician

practitioners are required to furnish information on their

Special Registration

applications that would demonstrate their specialized training. For example, the

clinician practitioner

could cite or provide information on board certification in a specialty, specialized training, or the percentage of the

clinician practitioner's

overall practice that falls within one of the specialized practices.

Mid-level practitioners

are, however, required to be board-certified under this proposed framework. DEA invites public comments on all facets of the proposed regulations, including this specific provision.

Particularly, DEA seeks input on whether other types of practitioners should be included if they can demonstrate specific training in expertise in managing conditions that are traditionally treated with Schedule II controlled substances. DEA also seeks input on alternative methods to ensure that practitioners seeking to prescribe Schedule II controlled substances pursuant to the

Advanced Telemedicine Prescribing Registration

have the appropriate training and expertise to do so safely.

See

Appendix B for Chart:

Which Special Registration for Telemedicine Do I Need as a Clinician Practitioner?

c. Telemedicine Platform Registration (Schedules II-V) Platform Practitioner Eligibility

To be eligible for the

Telemedicine Platform Registration

under proposed § 1301.11(c)(4),

covered online telemedicine platforms

would need to demonstrate that they have a legitimate need for a

Special Registration.

DEA has determined that

covered online telemedicine platforms

(defined under 21 CFR 1300.04), in their capacity as

platform practitioners,

have a legitimate need to dispense Schedules II through V controlled substances when they anticipate providing necessary services to introduce or facilitate connections between patients and

clinician practitioners

via telemedicine for the diagnosis, treatment, and prescription of controlled substances, are compliant with federal and state regulations, provide oversight over

clinician practitioners'

prescribing practices, and take measures to prioritize patient safety and prevent diversion, abuse, or misuse of controlled substances. The

platform practitioner

would be required to attest to its legitimate need on their

special registration

application. If, however, it is later discovered that the practitioner provided false information to obtain the

special registration

or used it for unlawful or inappropriate purposes, the practitioner could be found in violation of 21 U.S.C. 824(a), which could lead to penalties such as revocation or suspension of the registration.

As discussed previously, the registration of

covered online telemedicine platforms

within the

Special Registration

framework is necessary given the pivotal role they sometimes play in the delivery of healthcare through telemedicine. While these

covered online telemedicine platforms

may improve healthcare accessibility by connecting patients with

clinician practitioners,

their emergence also brings more, and sometimes easier, avenues to divert or abuse controlled substances, particularly when such entities have financial incentives tied to prescriptions and/or do not adequately screen the

clinician practitioners

utilizing their system or platform. The lack of proper oversight and verification of

clinician practitioners'

credentials open the door to “doctor shopping”

on the systems or platforms, particularly when bad actors are aware of, and exploit, the lack of oversight and credential verification by

covered online telemedicine platforms.

Bollmeier SG, Stevenson E, Finnegan P, Griggs SK.

Direct to Consumer Telemedicine: Is Healthcare from Home Best?

Mo Med. 2020 Jul-Aug;117(4):303-309. PMID: 32848261; PMCID: PMC7431063.

See also, Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications,

88 FR 30037, 30040 (May 10, 2023). As discussed in the First Temporary Rule, while the conduct of certain online telemedicine platforms has raised concerns and such platforms may be subject to investigation for problematic prescribing practices, many others have acted in good faith to expand access to care. “Doctor shopping is defined as seeing multiple treatment providers, either during a single illness episode or to procure prescription medications illicitly.” Sansone RA, Sansone LA. Doctor shopping: a phenomenon of many themes. Innov Clin Neurosci. 2012 Nov;9(11-12):42-6. PMID: 23346518; PMCID: PMC3552465.

2. Ancillary Registration: State Telemedicine Registrations

Pursuant to 21 U.S.C. 802(54), the

practice of telemedicine,

including such practice authorized under a

Special Registration,

must be “in accordance” or consistent with Federal and

State

law. Section 831(h)(1)(B) authorizes DEA to issue a

Special Registration

to a practitioner if the practitioner is registered under 21 U.S.C. 823(g) in the

state

in which the patient is located when receiving a prescription for controlled substance via telemedicine (a “823(g) patient state registration), subject to certain exceptions. While the proposed

Special Registration

framework must comply with these

statutory provisions, DEA is mindful that telemedicine is largely designed to overcome geographical constraints. Therefore, to reduce the administrative burden and cost on

special registrants,

DEA is proposing a limited type of 21 U.S.C. 823(g) registration for a lower registration fee, the

State Telemedicine Registration.

Pursuant to proposed § 1301.11(d), a

clinician special registrant

would be required to obtain a

State Telemedicine Registration,

which is a DEA-issued registration and not a registration issued by the individual states, for every state in which they intend to issue prescriptions for controlled substances to patients via telemedicine. Likewise, a

platform special registrant

would be required to obtain a

State Telemedicine Registration

for every state in which it dispenses Schedule II-V controlled substances to a patient. The

State Telemedicine Registration

would operate as an ancillary credential, contingent on the

Special Registration

held by the

clinician practitioner

platform practitioner.

In other words, a

State Telemedicine Registration

for a given state would allow the

special registrant

to prescribe only via telemedicine encounters as to that state, and only for the scheduled controlled substances authorized by their

Special Registration

(

i.e., Telemedicine Prescribing Registration, Advanced Telemedicine Prescribing Registration, or Telemedicine Platform Registration

Proposed 21 CFR 1301.11(d) stipulates that a practitioner's eligibility for the

State Telemedicine Registration

for a specific state depends on their authorization, such as state licensure or state-level registration, to prescribe or otherwise dispense controlled substances through telemedicine within that state. Consistent with the criteria for all 823(g) registrations, DEA will consider the public interest factors outlined in 21 U.S.C. 823(g)(1)(A)-(E) before granting a

State Telemedicine Registration.

The requirement of state authorization aligns with 21 U.S.C. 823(g)(1)(D), which assesses compliance with

state,

federal, and local laws regarding controlled substances.

Exemptions to the State Telemedicine Registration Requirement.

Section 21 U.S.C. 831(h)(1)(B) does, however, provide two categories of exemptions to the state registration requirement. Generally, a

clinician special registrant

would not be required to obtain a section 823(g) registration in each patient state to prescribe via telemedicine, if the

clinician special registrant

is either: (1) subject to a regulatory exemption applicable to all states pursuant to 21 U.S.C. 822(d),

or (2) the

clinician special registrant

is an employee or contractor of the VA.

Pursuant to 21 U.S.C. 822(d), “[t]he Attorney General may, by regulation, waive the requirement for registration of certain manufacturers, distributors, or dispensers if he finds it consistent with the public health and safety.”

21 U.S.C. 802(54)(A)(ii)(III).

As to the first category of exemptions, there is currently one regulatory exemption, promulgated pursuant to 21 U.S.C. 822(d), applicable to registration in all states. Specifically, 21 CFR 1301.23(a) waives registration “for any official of the U.S. Army, Navy, Marine Corps, Air Force, Space Force, Coast Guard, Public Health Service, or Bureau of Prisons who is authorized to prescribe, dispense, or administer, but not to procure or purchase, controlled substances in the course of his/her official duties.” The second category of exemptions is the one explicitly extended to VA employees or contractors by statute.

When an employee or contractor of the VA is acting in the scope of such employment or contract, and is registered under section 823(g) in

any state

or is utilizing the registration of a hospital or clinic operated by the VA registered under 21 U.S.C. 823(g), the prescriber would not need to possess a

State Telemedicine Registration

in each state in which a patient is located.

21 U.S.C. 802(54)(A)(ii)(III)(bb).

21 U.S.C. 831(h)(1)(B)(i)-(ii).

While proposed § 1301.11(d) incorporates these exemptions, those

clinician practitioners

who are exempted from the

State Telemedicine Registration

requirement remain subject to other

Special Registration

eligibility requirements and are required to identify all the states in which patients will be treated via telemedicine on their registration application for the

Telemedicine Prescribing Registration

or the

Advanced Telemedicine Prescribing Registration.

DEA must have this information to coordinate oversight and verify that

State Telemedicine Registration

-exempted

clinician special registrants

are operating within the boundaries of their exemption while upholding regulatory standards. The

State Telemedicine Registration

-exempted

clinician special registrants

would also be exempted from the $50 fee per state under proposed 21 CFR 1301.13(e)(1)(xiii), further discussed below.

See

Appendix C for Chart:

Which State Telemedicine Registrations Do I Need, If Any?

3. Special Registration Application Process

The

Special Registration

application process for obtaining the proposed

Telemedicine Prescribing Registration, Advanced Telemedicine Prescribing Registration,

and the

Telemedicine Platform Registration

would differ from the standard 21 U.S.C. 823(g) registration application process. The proposed amendments to 21 CFR 1301.13 outline the new

Special Registration

application requirements.

a. Special Registration Application, Cycles, Fees, Generally

Proposed 21 CFR 1301.13(e)(1)(xi)-(xv) summarizes the

Special Registration

Application, Cycle, and Fees. DEA proposes issuing a new registration application,

Form 224S

(

Application for Special Registration for Telemedicine Under the Controlled Substances Act

), tailored for

Special Registrations. Special Registration

applicants would use the

Form 224S

to apply for one of the three types of the

Special Registration

(

i.e., Telemedicine Prescribing Registration, Advanced Telemedicine Prescribing Registration,

Telemedicine Platform Registration

), as well as the

State Telemedicine Registrations

for each state in which telemedicine patients will be located. The regulations propose a tiered fee structure to address the administrative demands specific to the new business activities. The regulations propose a three-year cycle for the

Special Registrations

(

i.e., Telemedicine Prescribing Registration, Advanced Telemedicine Prescribing Registration,

and

Telemedicine Platform Registration

), as well as the

State Telemedicine Registrations

(

i.e., Clinician Practitioner State Telemedicine Registration

and the

Platform Practitioner State Telemedicine Registration

For any one of the three types of

Special Registration,

the registration fee would be $888. The fee for the

Platform Practitioner State Telemedicine Registration

would be $888 for each state in which a

State Telemedicine Registration

is sought; however, the

Clinician Practitioner State Telemedicine Registration

would be discounted to $50 for each state in which the

clinician practitioner

sought a

State Telemedicine Registration.

The fee for the

State Telemedicine Registration

for

clinician practitioners

is discounted to account for the expected

lower volume of telemedicine that would be conducted by

clinician practitioners

compared to

covered online telemedicine platforms.

The $50 registration fee for the

Clinician Practitioner State Telemedicine Registration

would be waived for those exempted from registration pursuant to 21 U.S.C. 831(h)(1)(B) and proposed 21 CFR 1301.11(c)(3). In DEA's preliminary assessment, the registration fees are reasonable and are expected to account for the full operating costs associated with the heightened administrative and resource demands on the Diversion Control Program that will arise from regulating a new registration class; however, DEA may adjust these fees as it acquires additional information about the new registration classes to ensure appropriate funding for regulatory oversight.

21 CFR 1301.21 exempts certain

clinician practitioner

applicants from payment of application fees for registration, including for

Special Registrations

and

State Telemedicine Registrations.

Pursuant to 21 U.S.C. 821, DEA is authorized to charge reasonable fees relating to registration and control of the dispensing (including prescribing) of controlled substances. Furthermore, 21 U.S.C. 886a(1)(C) requires those fees to be set at a level that ensures the recovery of the full costs of operating the various aspects of the Diversion Control. Program. For more information on fee scheduling, see Registration and Reregistration Fees for Controlled Substance and List I Chemical Registrants, 85 FR 44710-44734 (July 24, 2020).

b. Supplemental Requirements on Special Registration Application (Form 224S)

Special Registered Location.

Pursuant to proposed § 1301.13(k)(1), all

Special Registration

applicants would be required to designate one of their existing 21 U.S.C. 823(g) registered locations as the registered location/physical address (“

special registered location

”) of their

Special Registration.

The

special registered location

would serve as the physical point of contact for DEA telemedicine inquires and compliance actions. As will be further discussed below, the proposed rule would also mandate that the records arising from telemedicine encounters under the

Special Registration

be maintained at the

special registered location.

Such centralized recordkeeping would allow DEA to more efficiently review records and ensure that prescriptions are being issued in accordance with DEA regulations. Proposed § 1301.13(k)(1) would provide an exemption for applicants who are exempted from the

State Telemedicine Registration

requirement under proposed § 1301.11(d); however, such exempted persons would be required to provide another physical address on the application to serve as their

special registered location.

See

Proposed 21 CFR 1304.04(j).

Form 224S Supplementary Disclosures and Attestations.

Proposed 21 CFR 1301.13(k)(2) would require the

Special Registration

applicant to provide certain disclosures and attestations on the Form 224S. Such information would enhance transparency, patient safety, and anti-diversion efforts. First, proposed § 1301.13(k)(2)(i) would require

platform practitioners

applying for the

Telemedicine Platform Registration

to attest to all employment, contractual relationships, or professional affiliations with any

clinician special registrant

and Online Pharmacy and their respective registration numbers on the Form 224S. Likewise, proposed § 1301.13(k)(2)(ii) would require

clinician practitioners

applying for the

Telemedicine Prescribing Registration

or the

Advanced Telemedicine Prescribing Registration

to attest to all employment, contractual relationships, and professional affiliations, including but not limited to those with

covered online telemedicine platforms

(and the respective online telemedicine platform's

Telemedicine Platform Special Registration number,

if applicable) on the Form 224S. By understanding each prescriber's professional associations, DEA can more effectively evaluate the prescriber's qualifications, conflicts of interest, and compliance with DEA regulations.

Second, proposed § 1301.13(k)(2)(iii) would require that

clinician practitioners

and

platform practitioners

applying for a

Special Registration

to attest that they have devised, and are committed to maintaining, anti-diversion policies and procedures.

See

Telemedicine Listening Sessions, Dr. Shabana Khan (American Psychiatric Association and American Academy of Child and Adolescent Psychiatry), 38:16-19 (Sept. 12, 2023) (recommending that DEA could require the reporting of the prescriber's employer to hold the telemedicine employers accountable).

Third, proposed § 1301.13(k)(2)(iv) would require

clinician practitioners

applying for the

Advanced Telemedicine Prescribing Registration

to disclose their practice specialties,

e.g. hospice care

palliative care.

DEA would use this information in conjunction with other investigative information to help detect and prevent diversion of controlled substances via telemedicine. This would include circumstances where

clinician practitioners

appear to be prescribing medications for conditions unrelated to their practice specialties. DEA would also use this information as needed to check the applicant's eligibility for the

Advanced Telemedicine Prescribing Registration,

which is limited to certain specialized physicians and

mid-level practitioners

treating vulnerable patient populations who have a legitimate need to prescribe Schedule II controlled substances.

As discussed above, under the proposed 21 CFR 1301.11(c)(3), only psychiatrists,

hospice care

physicians,

palliative care

physicians, physicians rendering treatment at

long term care facilities,

pediatricians, neurologists, and

mid-level practitioners

board certified in the treatment of psychiatric or psychological disorders,

hospice care, palliative care,

pediatric care, or neurological disorders unrelated to the treatment and management of pain, would be eligible for the

Advanced Telemedicine Prescribing Registration.

Lastly, proposed § 1301.13(k)(2)(v) would require that, for each type of

Special Registration,

the applicant required to attest to their legitimate need on their

special registration

application. If, however, it is later discovered that practitioner provided false information to obtain the

Special Registration

or used it for unlawful or inappropriate purposes, they could be found in violation of 21 U.S.C. 824(a), which could lead to penalties such as revocation or suspension of registration.

c. Notification of Application Changes; Modifications (Form 224S-M)

Proposed 21 CFR 1301.13(l) would require

special registrants

to promptly notify DEA of any changes to the information provided in their original

Special Registration

application (Form 224S) within 14 business days on a Form 224S-M (

Application for Changes and Modifications to Special Registration

). For example, if a

clinician special registrant

began employment with, or otherwise entered an arrangement with, a new DTC online telemedicine platform not previously disclosed on their original Form 224S, the

clinician special registrant

would be required to submit a Form 224S-M to DEA within 14 business days of any such change. The Form 224S-M would also be used by

clinician special registrants

and

platform special registrants

to make modifications to their

Special Registration.

For example, the

special registrant

would submit a Form 224S-M to apply for additional

State Telemedicine Registrations

to engage in telemedicine in states for which the

special registrant

did not originally apply on their Form 224S.

4. Special Registration for Telemedicine Actions

a. Approval and Denial of Special Registration Applications

Proposed amendments to 21 CFR 1301.35 address the approval and denial criteria that would be considered on an application for

Special Registration

under 21 U.S.C. 831(h). The proposed amendment to § 1301.35(a) states that the Administrator shall issue a Certificate of Registration (DEA Form 223) to a

Special Registration

applicant if: (1) the

Special Registration

applicant satisfies the eligibility requirements specified at proposed 21 CFR 1301.11(c)(2) (

Telemedicine Prescribing Registration

), proposed 21 CFR 1301.11(c)(3) (

Advanced Telemedicine Prescribing Registration

), proposed 21 CFR 1301.11(c)(4) (

Telemedicine Platform Registration

) or proposed 21 CFR 1301.11(d) (

State Telemedicine Registration

); and (2) after considering the public interest factors provided at 21 U.S.C. 823(g)(1)(A)-(E), the Administrator has determined that the

Special Registration

will be consistent with the public interest.

By evaluating

Special Registration

applicants on the eligibility requirements and considering the public interest factors under Section 823(g), DEA can ensure that only qualified practitioners, whether a

clinician practitioner

or a

platform practitioner,

who prioritize public safety and regulatory compliance are granted

Special Registrations for Telemedicine.

As is required for applications for other registrations (issued under 21 U.S.C. 823 and 21 U.S.C. 958), proposed 21 CFR 1301.35(a) requires the Administrator—if intending to deny an application—to issue an

Order to Show Cause

pursuant to 21 CFR 1301.37,

and, if requested by the applicant, hold a hearing on the application pursuant to 21 CFR 1301.31 for

Special Registration

Applications.

28 CFR Pt. 0, Subpt. R., App., Sec. 7 delegates the authority to sign final orders connected with the suspension, denial, or revocation of registration to the Deputy Assistant Administrator of the DEA Office of Diversion Control.

Proposed 21 CFR 1301.35(d) would specify what information a Certificate of Registration (DEA Form 223) issued for a

Special Registration

shall contain: name;

special registered location; Special Registration for Telemedicine

(

Telemedicine Prescribing Registration, Advanced Telemedicine Prescribing Registration,

Telemedicine Platform Registration

), and

State Telemedicine Registration(s);

the activity authorized by the

Special Registration,

the Schedules and/or Administration Controlled Substances Code Number (as set forth in part 1308 of this chapter) of the controlled substances which the registrant is authorized to handle; the amount of fee paid (or exemption) for each registration, and the expiration date of each registration. Proposed 21 CFR 1301.35(d) would also require a special registrant to maintain the Certificate of Registration at the

special registered location

in a readily retrievable manner and to permit inspection of the certificate by any official, agent or employee of the DEA or of any Federal, State, or local agency engaged in enforcement of laws relating to controlled substances.

b. Suspension and Revocation of Special Registrations

The proposed amendments to 21 CFR 1301.36 outline when

Special Registrations for Telemedicine

(

Telemedicine Prescribing Registration, Advanced Telemedicine Prescribing Registration,

and

Telemedicine Platform Registration

), and

State Telemedicine Registrations

may be suspended or revoked. Proposed 21 CFR 1301.36(c) would provide that such

Special Registrations for Telemedicine

can be suspended or revoked based on the grounds specified in 21 U.S.C. 824(a), which are fundamentally designed to authorize DEA to intervene when registrants jeopardize the responsible handling of controlled substances. A

Special Registration

is contingent on the good standing of the registrant's other DEA registrations; therefore, proposed 21 CFR 1301.36(k) stipulates that the suspension or revocation of any registration under 21 U.S.C. 823 will trigger an automatic suspension or revocation of any registration issued under 21 U.S.C. 831. These automatic suspensions and revocations are designed to prevent registrants who have had one registration suspended or revoked due to non-compliance or risk to patient safety, from exploiting alternate registrations.

B. Special Registration Prescriptions Issued by Clinician Special Registrants Under 21 CFR Part 1306

Proposed 21 CFR 1306.41 through 1306.47 provide heightened requirements for

clinician special registrants

when they issue

special registration prescriptions.

Along with these heightened

special registration prescription

requirements,

clinician special registrants

would remain obligated to comply with all prescription regulations required under their 21 U.S.C. 823(g) registration. The combination of heightened telemedicine standards and continued adherence to existing regulations ensures that the quality and integrity of medical practice are maintained, even in the evolving landscape of remote healthcare services. Generally, these proposed regulations address the manner in which prescriptions are issued by

clinician special registrants,

and certain elements required to be a part of

special registration prescriptions.

1. Manner of Issuance of Special Registration Prescriptions

Prescription Origination within the United States.

Proposed 21 CFR 1306.41 would require that the

clinician special registrant

be physically present in the United States when conducting a telemedicine encounter and issuing a

special registration prescription.

Additionally, proposed 21 CFR 1306.41 would require that the

clinician special registrant

hold the proper licensure and authorization within the state and territory where the practitioner is located when the telemedicine encounter takes place.

For the purposes of this proposed rule, the “United States” means the 50 states of the United States of America and the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Commonwealth of the Northern Mariana Islands, the U.S. Virgin Islands, America Samoa, Wake Island, Midway Islands, Kingman Reef, Johnston Atoll, and any other trust territory or possession of the United States. This proposed requirement ensures that DEA retains jurisdictional control over

special registration prescriptions

and maintains clear boundaries on where these prescriptions are issued, ensuring compliance with U.S. laws and regulations. Restricting

clinician special registrants

from operating outside the U.S. also minimizes the risk associated with international boundaries, such as different regulatory frameworks and potential challenges in oversight and accountability.

The practitioner would also be required to be licensed and authorized to practice telemedicine in the state where the patient is located pursuant to the relevant

State Telemedicine Registration. See

proposed 21 CFR 1301.11(d).

Electronic Prescribing for Controlled Substances (EPCS).

Proposed 21 CFR 1306.42 requires all

special registration prescriptions

be issued through EPCS.

For the practice of telemedicine, in which physical practitioner-patient interactions do not exist, EPCS would be instrumental in securing the prescription process. It would establish a traceable and secure platform that reduces the risk of unauthorized access

and forgeries. Moreover, the majority of states have enacted EPCS mandates to combat the opioid crisis by focusing on opioid access and enhanced oversight of possible misuse.

According to one 2021 study of New York's e-prescribing mandate, the mandate reduced the rate of overdoses involving natural and semi-synthetic opioids by 22 percent.

EPCS offers a robust and accountable system that prevents misuse and diversion of controlled substances, helping to maintain the integrity of prescribing among

clinician special registrants.

Electronic Prescriptions for Controlled Substances,

75 FR 16236 (March 31, 2010).

EPCS Mandates: Ultimate Guide to 2023 Deadlines | RXNT (Available: https://www.rxnt.com/epcs-mandates/).

Abouk R, Powell D.

Can Electronic Prescribing Mandates Reduce Opioid-Related Overdoses?

Econ Hum Biol. 2021 Aug;42:101000. doi: 10.1016/j.ehb.2021.101000. Epub 2021 Apr 9. PMID: 33865194; PMCID: PMC8222172 (Available:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8222172/

Nationwide Prescription Drug Monitoring Program (PDMP) Check.

Proposed 21 CFR 1306.43 requires that

clinician special registrants

perform a check of relevant PDMPs. For a period of three (3) years from the date that a final rule becomes effective, before issuing any

special registration prescription

for controlled substance to a patient, the

individual special registrant

would be required to check the PDMPs for: (1) the state or territory where the patient is located; (2) state or territory where the

clinician practitioner

is located; and (3) any state or territory with PDMP reciprocity agreements with either the state or territory where the patient is located or the state or territory where the

clinician practitioner

is located. While the proposed regulation would require, at a minimum, that

clinician special registrants

check these three categories, DEA encourages

clinician special registrants

to check any other state PDMP that the registrant determines to be clinically appropriate.

After three years, however, the

individual special registrant

would be required, before issuing any

special registration prescription

for controlled substances to a patient, to check the PDMPs of all 50 states of the United States and any other U.S. district or territory that maintains its own PDMP. This requirement for a broader, nationwide PDMP check would not begin until three (3) years after the final rule's effective date, to allow registrants and industry sufficient time to comply with the new requirement. If, however, there is no mechanism to perform such a nationwide check after these three years, then

individual special registrants

would remain required to continue performing PDMPs checks of the states in the three categories described above, and

individual special registrants

would only be able to issue

special registration prescriptions

for Schedule II controlled substances to patients located within the same state as the

individual special registrant, i.e.,

where there is an intra-state practitioner-patient relationship. The proposed nationwide PDMP check requirement is intended to ensure that

clinician practitioners

and pharmacists have full visibility of a patient's controlled substance prescription history, not to proactively furnish DEA with access to this data. Accordingly, this rule does not propose that DEA would gain any new avenues, by means of this rule, to collect information from state PDMPs beyond what is otherwise authorized by federal and state laws.

This delayed nationwide PDMP check requirement also reflects that the fragmented nature of PDMPs across states and territories has created challenges for healthcare providers in obtaining comprehensive patient data, particularly in cases involving telemedicine. In the context of telemedicine, the extension of medical services across state boundaries increases the complexity of controlling diversion of controlled substances. Telemedicine allows patients to consult

clinician practitioners

located in different states, creating a scenario where patients might seek multiple prescriptions from different

clinician practitioners

practicing in different regions,

i.e.

“doctor shop,” by exploiting the current fragmented nature of PDMPs across the states. Moreover, the absence of in-person interaction with telemedicine patients may limit the practitioner's ability to gauge whether patients are being honest about their medical history, potentially enabling the concealment of pertinent information related to controlled substances. During the Telemedicine Listening Sessions, various speakers highlighted the challenges resulting from the fragmented nature of PDMPs across states and territories and called for enhanced interoperability of PDMPs nationwide; some speakers also advocated for a unified national or federal PDMP to address these concerns more effectively.

Telemedicine Listening Sessions, Dr. Shabana Khan (American Psychiatric Association and American Academy of Child and Adolescent Psychiatry), 36:21-37:1, 38:6-10, 41:20-42:6 (Sept. 12, 2023); Dr. Helen Hughes (John Hopkins Medicine) 69:3-10 (Sept. 12, 2023); Jodi Sullivan (Investigations Medicare Drug Integrity Contractor), 197:5-13, 197:24-198:21 (Sept. 12, 2023); and Dr. Jeffrey Chester, 256:22-257:10 (Sept. 12, 2023); Telemedicine Listening Sessions, Dr. Felicia Bailey, 19:6-13 (Sept. 13, 2023); Dr. Connie Guille (Medical University of South Carolina), 52:11-20 (Sept. 13, 2023); Christa Natoli (CTel), 151:15-152:3 (Sept. 13, 2023); John Wells (Louisiana State University), 160:4-8 (Sept. 13, 2023); Dan Golden (East Coast Telepsychiatry), 215:6-216:23 (Sept. 13, 2023); Dr. Shirley Reddoch, 235:14-18 (Sept. 13, 2023); Dr. Stephen Martin (Boulder Care), 128:24-129:10 (Sept. 13, 2023); and Dr. Ujjal Ramtekkar (Quartet Health), 142:10-18 (Sept. 13, 2023).

To address these risks to public health and safety, it is imperative that

clinician special registrants

ultimately be required to perform this comprehensive PDMP check of all 50 states, and any other U.S. district or territory that maintains its own PDMP. This comprehensive nationwide PDMP check would provide the

clinician special registrants

a comprehensive view of the patient's prescription history, helping to prevent over-prescribing and mitigating the risk of patients engaging in “doctor shopping” to obtain multiple controlled substance prescriptions across state lines. DEA acknowledges that it is currently unlikely that any one healthcare provider has access to all PDMPs nationwide. However, DEA also recognizes that current efforts to standardize, centralize, and interconnect PDMP data are making headway. These initiatives, aimed at creating a more unified and accessible system, offer a feasible future solution to bridge the gap and improve the accessibility of vital prescription information.

Special Registration Prescriptions and Audio-Video Telecommunication Systems.

Proposed 21 CFR 1306.44(a) mandates that a

clinician special registrant

utilize both audio and video components of an

audio-video telecommunications system

to prescribe under the

Special Registration

framework for every telemedicine encounter whether an initial visit or subsequent visit or follow-up. This requirement underscores the critical need to not only audibly, but visually, assess patients when prescribing controlled substances. Controlled substances, which often carry a substantial risk of misuse or diversion, require a more comprehensive evaluation. Visual observation of the patient is crucial for providers, because it communicates valuable information that cannot be obtained through other means and allows for more effective identity verification.

By observing a

patient's physical appearance, demeanor, and body language, providers can gather important indications of misuse or diversion of controlled substances. Though DEA has permitted audio-only telemedicine on a temporary basis for patients during and immediately after the COVID-19 PHE, the current landscape calls for a reevaluation. The Department of Health and Human Services (HHS) declared an end to the Federal PHE for COVID-19 under section 319 of the Public Health Service Act on May 11, 2023,

and as pointed out by some researchers, the “risk benefit calculation of audio-only visits has changed, and it is increasingly important to protect patients from potentially lower-quality audio-only visits,” especially when visual observations are critical.

At the Telemedicine Listening Sessions, various speakers advocated for the use of audio-video telemedicine specifically.

Expressing their concerns about the use of audio-only telemedicine, one speaker said, “we require video visits. On rare occasions we do the telephone. Just for the fact you can lay eyes on the people. They may tell you they're perfectly fine, but they may have tears coming down their face. They may have physical problems. They may have meth marks. You know, things that people need to see. So video's important.”

See

Faustinella F.

The Power of Observation in Clinical Medicine

. Int J Med Educ. 2020 Nov 30;11:250-251. doi: 10.5116/ijme.5fb9.1c9b. PMID: 33254147; PMCID: PMC7883801 (Available:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7883801/

); and Bramstedt, Katrina, Ph.D., MA.

The Use of Visual Arts as a Window to Diagnosing Medical Pathologies

. AMA J Ethics. 2016;18(8):843-854. doi: 10.1001/journalofethics.2016.18.8.imhl1-1608 (Available:

https://journalofethics.ama-assn.org/article/use-visual-arts-window-diagnosing-medical-pathologies/2016-08

Fact Sheet: End of the COVID-19 Public Health Emergency,

Press Release, U.S. Dept. of Health and Human Services (HHS)(May 9, 2023),

https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html

Rethinking the Impact of Audio-Only Visits on Health Equity,

RAND Corp. (Dec. 17, 2021),),

https://www.rand.org/blog/2021/12/rethinking-the-impact-of-audio-only-visits-on-health.html

Telemedicine Listening Sessions, Melanie Melville (Legacy Community Health), 96:1-16 (Sept. 12, 2023); Bruce Bassi, M.D., 29:18-30:3 (Sept. 13, 2023); Connie Guille (Medical University of South Carolina), M.D., 53:21-54:1 (Sept. 13, 2023).

Telemedicine Listening Sessions, Dan Golden, 218:15-219:6 (Sept. 13, 2023).

The utilization of

audio-video telecommunication systems

—as opposed to audio-only communication technology—not only offers advantages in helping prevent diversion, but it also allows the

clinician special registrant

to visually confirm the patient's identity in real time. This would be achieved by comparing the patient to their existing photo identification on file, which will exist in the vast majority of cases given the requirements under proposed 21 CFR 1304.04(i). This direct visual verification serves as a further safeguard against the diversion of controlled substances during telemedicine encounters.

See

Telemedicine Listening Sessions, Kevin Duane. 202:21-203:9 (Sept. 12, 2023); and Bruce Bassi, M.D., 31:12-20 (Sept. 13, 2023).

Schedule III-V Special Registration Prescriptions for Opioid Use Disorder.

Proposed 21 CFR 1306.44(b) would allow

clinician special registrants

to issue

special registration prescriptions

for, and

platform special registrants

to dispense, Schedule III-V controlled substances approved by the FDA for the treatment of Opioid Use Disorder (“OUD”) through the use of an

audio-only telecommunications system

as described in 42 CFR 410.78(a)(3), provided that the treatment was initiated through the use of an

audio-video telecommunications system

as defined in the proposed 1300.04 of this chapter. According to one survey of 866 mental health (MH), primary care (PC), and specialty care (SC) clinicians in the Department of Veterans Affairs New England Healthcare System (VANEHS), less than one-third of the clinicians surveyed rated phone as equivalent to or higher in quality when treating new patients. However, the survey indicated that support for such audio-only telecommunications increased significantly when treating established patients. These results highlight the importance of visual assessments for new patients, while showing that audio-only telecommunications may be more acceptable or useful once a patient is established.

Connolly SL, Miller CJ, Gifford AL, Charness ME. Perceptions and Use of Telehealth Among Mental Health, Primary, and Specialty Care Clinicians During the COVID-19 Pandemic.

JAMA Netw Open

. 2022;5(6):e2216401. doi:10.1001/jamanetworkopen.2022.16401.

Currently, the only Schedule III-V narcotic drug approved by the FDA for the treatment of OUD is buprenorphine.

DEA's proposed authorization for the use of

audio-only telecommunications systems

for the treatment of OUD is rooted in the unique nature of OUD treatment. The complex and long-term management of OUD often necessitates a continuum of care that might be best accommodated through flexibility in telecommunication methods. Expanding the circumstances under which

clinician practitioners

are authorized to prescribe buprenorphine via telemedicine encounters, including audio-only encounters, would increase access to treatment for those individuals with OUD who may not want to seek treatment, or are unable to seek treatment, due to various economic, geographical, sociological, and logistical reasons.

42 CFR 8.12(h)(2)(ii).

Many OUD patients may lack the financial means to obtain in-person treatment traditionally or through audio-video telemedicine encounters. OUD patients who are unhoused, unemployed, or facing other challenges may find it prohibitive to afford devices capable of audio-video telemedicine encounters or consistent access to wireless internet and/or data plans adequate to support bandwidth demands of telemedicine encounters.

The estimated number of deaths from opioid overdoses for the 12-month period ending in October 2023 were 79,695, with a peak of 83,985 opioid overdose deaths for the 12-month period ending in May 2023.

Access to buprenorphine decreases the risk of overdosing,

and increasing access to buprenorphine after a drug overdose has also been associated with a reduced risk of death.

This allowance acknowledges the specific challenges faced by OUD patients and the importance of ensuring consistent therapeutic relationships with limited interruptions.

DeLaCruz et al.,

Telemental Health for the Homeless Population: Lessons Learned when Leveraging Care,

(Dec. 8, 2022)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9734763/

Provisional Drug Overdose Death Counts, National Center for Health Statistics, Centers for Disease Control and Prevention.

https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm

. Updated March 3, 2024. Last accessed April 12, 2024.

Dadiomov,

et al., Buprenorphine and naloxone access in pharmacies within high overdose areas of Los Angeles during the COVID-19 pandemic,

Harm Reduction Journal (June 29, 2022),

https://harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-022-00651-3

. Last accessed April 11, 2024.

Larochelle,

et al., Medication for Opioid Use Disorder After Nonfatal Opioid Overdose and Association with Mortality,

Annals of Internal Medicine, (August 07, 2018),

https://www.acpjournals.org/doi/10.7326/M17-3107

. Last accessed April 11, 2024.

It also important to highlight that the

Expansion of Buprenorphine Treatment via Telemedicine Encounter

final rule (RIN 1117-AB78), jointly promulgated with HHS elsewhere in this issue of the

Federal Register

, allows a DEA-registered practitioner without a

Special Registration

to issue a prescription for a Schedule III-V controlled substance approved by the FDA for the treatment of OUD via audio-only or audio-video telemedicine for an initial consecutive six-month supply. Following the initial six-month supply, practitioners may prescribe the controlled substance by other forms of the

practice of telemedicine

authorized under the CSA (such as pursuant to a

Special

Registration

) or after conducting an in-person medical evaluation.

This proposed Special Registration NPRM would not preclude a

clinician special registrant

from utilizing the authority under the

Expansion of Buprenorphine Treatment via Telemedicine Encounter

final rule (RIN 1117-AB78) for the prescription of buprenorphine for the treatment of OUD. However, after the six-month supply has been completed, a

clinician special registrant

would need to initiate further prescribing of the controlled substance through an

audio-video telecommunications system

. After this initial audio-video telemedicine encounter, the

clinician special registrant

may then use

audio-only telecommunications systems

to prescribe buprenorphine for the treatment of OUD to the patient for the duration of the practitioner-patient relationship.

DEA's proposed authorization of audio-only telemedicine follow-ups under the

Special Registration

framework does not or should not be taken to imply that buprenorphine cannot be or is not diverted. Some presenters spoke to these issues during the Telemedicine Listening Sessions. According to one presentation, there is a “robust illicit market for buprenorphine,” and anecdotal reports of patients are selling buprenorphine to fund abuse of other controlled substances.

Another presenter said that drugs like suboxone and buprenorphine, prescribed to treat OUD, are used as a “currency” to purchase other drugs like methamphetamine

and that in his community, “if methamphetamine is involved, you can pretty much be assured the diversion of buprenorphine is involved.”

Telemedicine Listening Sessions, Daniel Reck (Matclinics), 104:3-9. (Sept. 12, 2023).

Telemedicine Listening Sessions, Jerome Cohan (Catalyst Health Solutions), 268:2-20. (Sept. 12, 2023).

Such anecdotal information, however, must be considered in the context of the nation's opioid crisis, as well as recent data showing a lower risk of diversion for buprenorphine relative to other controlled substances. In November 2023, a report by the Office of the Inspector General of HHS found that 97 percent of Part D enrollees received the recommended amounts or less of buprenorphine for OUD in 2022, suggesting that the risk of misuse or diversion of buprenorphine in Medicare Part D may be low.

Considering this data and the additional proposed safeguards in this rule for

special registration prescriptions,

including the initiation of buprenorphine through audio-video telemedicine encounters, DEA believes that expanding access to buprenorphine through audio-only follow-ups outweighs the relatively lower risk of misuse and diversion of buprenorphine.

U.S. Dept. of Health and Human Services, Office of Inspector General, OEI-02-24-00130,

Data in Brief: The Risk of Misuse and Diversion of Buprenorphine for Opioid Use Disorder in Medicare Part D Continues to Appear Low: 2022

(Nov. 2023) (Available:

https://oig.hhs.gov/oei/reports/OEI-02-24-00130.pdf

Schedule II Controlled Substance Prescriptions.

Proposed 21 CFR 1306.45 requires that every

special registration prescription

for a Schedule II controlled substance be issued by a

clinician special registrant

that maintains the

Advanced Telemedicine Prescribing Registration,

who is issuing the prescription while the

clinician special registrant

is practicing within their given medical specialty. Proposed 21 CFR 1306.45(a) imposes further conditions on

clinician special registrants

who are pediatricians or board-certified in pediatric care and requires the mandatory presence of the minor's parent or guardian when the

clinician special registrant

prescribes a Schedule II controlled substance to the minor. This proposed provision is rooted in DEA's commitment to safeguarding the well-being of minors, particularly given the substantial risks associated with Schedule II controlled substances, including opioids.

This safeguard aligns with the broader intent of the

Ryan Haight Act,

which was enacted following the death of Ryan Haight, who tragically died after obtaining prescription opioids online without a valid prescription and without having ever been seen by the prescribing physician. Ryan Haight was only 17 years old when he purchased the opioids, and 18 years old when he died.

The direct parental or guardian supervision would help to discourage any potential misuse or attempts to acquire a Schedule II controlled substance for non-medical reasons. While DEA acknowledges potential concerns of minors who may perceive this as an intrusion on their privacy, it is crucial to balance this consideration against the inherent risks associated with Schedule II controlled substances in particular. It should also be noted that this proposed requirement would not extend to cases where a pediatrician prescribes a Schedule III through V controlled substance under the

Special Registration

framework.

U.S. Drug Enforcement Administration, Prescription for Disaster: How Teens Abuse Medicine (Accessed: Dec. 13, 2023) (Available:

https://www.dea.gov/sites/default/files/resource-center/Publications/DEA_Prescription-For-Disaster_508ver.pdf

Given the higher potential for abuse and dependence of Schedule II controlled substances, 21 CFR 1306.45 proposes two additional requirements when issuing a

special registration prescription

for a Schedule II controlled substance; DEA anticipates imposing one or both of the proposed requirements based on the comments received by stakeholders. The first of the two proposed requirements, under proposed 21 CFR 1306.45(b), would require that the

clinician special registrant

be physically located in the same state as the patient when issuing a

special registration prescription

for a Schedule II controlled substance. Under this same-state limitation, when issuing a Schedule II

special registration prescription,

clinician special registrant

would not only have to have the

Advanced Telemedicine Prescribing Registration,

and a

State Telemedicine Registration

in the state in which the patient is located, but the

clinician special registrant

would also have to be physically located in the same state as the patient.

Requiring the

clinician special registrant

to be in the same state as the patient helps mitigate the risks associated with the prescribing of Schedule II controlled substances across state lines. Geographical proximity enables more effective oversight by state regulatory agencies to ensure compliance with state laws governing the prescription of these high-risk medications and will make it more likely that the

clinician special registrant

can see the patient in-person should any medical or diversion concerns arise.

It should be noted, however, that the

Special Registered Location

associated with the

Advanced Telemedicine Prescribing Registration

would not have to be in the same state in which the patient was issued the Schedule II controlled substance.

The second of the two proposed requirements, under proposed 21 CFR 1306.45(c), would require that the average number of

special registration prescriptions

for Schedule II controlled substances constitutes less than 50 percent of the total number of Schedule II prescriptions issued by the

clinician special registrant

in their telemedicine and non-telemedicine practice in a calendar month. Limiting the proportion of Schedule II prescriptions issued through telemedicine would help to manage the risks associated with the prescribing of Schedule II controlled substances by ensuring that a significant portion of these prescriptions are issued following in-person medical evaluations, which can provide a more comprehensive assessment of the

patient's medical history and condition than can be done remotely.

State Laws Applicable to Special Registration Prescriptions.

Proposed 21 CFR 1306.46 would require special registrants, when issuing a

special registration prescription,

to comply with the laws and regulations of the state in which the special registrant is located during the telemedicine encounter resulting in the

special registration prescription

; the state in which the patient is located during the telemedicine encounter resulting in the

special registration prescription

; and any state or states in which the special registrant maintains a DEA registration to dispense controlled substances or a medical license, to the extent that the law or regulation applies to telemedicine encounters between practitioners and patients located in the states in which the special registrant and the patient are each located during the telemedicine encounter resulting in the

special registration prescription.

This provision would require that the practice of telemedicine be conducted in accordance with applicable state laws set forth in 21 U.S.C. 802(54).

2. Additional Elements on a Special Registration Prescription

A prescription for controlled substances, whether issued via telemedicine or not, must contain the elements specified in 21 CFR 1306.05(a), which encompass the signature of the prescriber, issue date, patient's full name and address, drug details (name, strength, dosage form, and quantity), directions for use, and the practitioner's name, address, and registration number.

Proposed 21 CFR 1306.47 would require two additional elements for

special registration prescriptions:

(1) the

Special Registration

numbers of the

clinician practitioner

and, if a

platform practitioner

facilitated the prescription, the

platform practitioner

; and (2)

State Telemedicine Registration

numbers of the

clinician practitioner

and, if a

platform practitioner

facilitated the prescription, the

platform practitioner

(unless exempted from obtaining a

State Telemedicine Registration

under proposed 21 CFR 1301.11(d)).

Proposed 21 CFR 1306.47(c) would add a corresponding liability provision for these new requirements, to track the current provision in 21 CFR 1306.05(f) that imposes a corresponding liability on a pharmacist who fills a prescription not prepared in the form prescribed in 21 CFR 1306.05(a).

https://www.fda.gov/drugs/development-approval-process-drugs/national-drug-code-database-background-information; https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory.

Proposed 21 CFR 1306.47(b) would not require that the Special Registrant provide the registration number associated with their conventional registration under 21 U.S.C. 823(g).

The inclusion of the

Special Registration

numbers of the

clinician practitioner

and the

platform practitioner

(if a platform practitioner facilitated the prescription) would provide the pharmacist the information necessary to determine whether the

clinician practitioner

has the authority to prescribe a Schedule II controlled substance under the

Special Registration

framework, and that the

platform practitioner

(if a

platform practitioner

facilitated the prescription) has the authority to dispense a Schedule II controlled substance. The inclusion of

State Telemedicine Registration

numbers would provide pharmacists the information necessary to verify that patients are only being prescribed

special registration prescriptions

special registrants

authorized to practice in the specific state where the patient is located; registered pharmacists would be able to verify these registration numbers on DEA's

CSA Registration Validation Tool

Pharmacists occasionally encounter what they may perceive as “red flags” for certain telemedicine prescriptions, which can stem from the nature of telemedicine itself, where patients may receive prescriptions from prescribers located at distances far away (both inside and outside the state where the patient is located). The geographical distance can raise doubts about the legitimacy of the prescription and could lead pharmacists to question its validity and refuse to fill the prescription. By verifying the

State Telemedicine Registration

numbers, pharmacists would be provided a level of assurance that a

special registration prescription

is legitimate when it originates from a prescriber located a significant distance from the patient. For

clinician special registrants

exempted from obtaining

State Telemedicine Registrations,

proposed 21 CFR 1306.47(a) would require them to instead provide a notation on the prescription identifying the state in which the patient is located.

C. Recordkeeping and Reporting Under 21 CFR Part 1304

Clinician special registrants

would remain subject to their existing recordkeeping and reporting obligations under their 21 U.S.C. 823(g) registrations; however, they would also be subject to supplementary requirements within the

Special Registration

framework.

Clinician special registrants

would be required to establish and maintain photographic records for patient verification and maintain their

special registration prescription

records at their designated

special registered location. Platform special registrants,

on the other hand, would be required to maintain and update credential verification and documentation records. As to data reported to DEA, pharmacies dispensing

special registration prescriptions

would be required to report monthly aggregated

special registration prescription

data on Schedule II controlled substances and certain Schedule III-V controlled substances, and

special registrants

would be required to report annually aggregated information about their telemedicine practice, including the number of new patients they treat through telemedicine, and the total number of

special registration prescriptions

for Schedule II controlled substances, and certain Schedule III-V controlled substances, they dispensed for the preceding year.

1. Patient Verification Photographic Record

Proposed 21 CFR 1304.04(i) would generally require that a

clinician special registrant,

or a delegated employee or contractor under the direct supervision of the

clinician special registrant,

verify the identity of a patient seeking treatment via telemedicine by requiring that the patient present a state or federal government-issued photo identification card through the camera of the

audio-video telecommunications system.

At the first telemedicine encounter, the

clinician special registrant

would also be required to capture a photographic record of the patient presenting their federal or state-issued photo identification card or other acceptable documents and use the photographic records to confirm the patient's identity in subsequent telemedicine encounters.

If for some reason the patient does not consent to their photo being captured, proposed 21 CFR 1304.04 would allow the

clinician special registrant

(or their delegated employee or contractor under their direct supervision) to accept a copy of the patient's federal or state government-issued photo identification card or other forms of documentation provided by the patient. To ensure that patient privacy is protected, the patient verification photographic records would be securely stored in the patient's medical record or chart, separate from the

special registration prescription

records/data reported to DEA under proposed 21 CFR 1304.40.

Recognizing that not all persons may have a photo identification card,

proposed 21 CFR 1304.04(i)(1) would allow a

clinician special registrant,

or a delegated employee or contractor under the direct supervision of the

clinician special registrant,

to verify the identity of the patient with other forms of documentation, and would require the

clinician special registrant

to maintain a record of how they verified the patient's identity and what documents were used to verify the patient's identity. For example, a

clinician special registrant

(or their delegated employee or contractor under their direct supervision) might verify patient identity by observing a patient's pay stub and/or a bill with the patient's home address, a letter provided by a shelter employee if the patient is unhoused, or a patient's school identification card or report card if the patient is a minor.

This proposed requirement would ensure that the patient's identity is verified at each telemedicine encounter, reducing the risk of unauthorized individuals diverting controlled substances. Throughout the Telemedicine Listening Sessions, various presenters underscored the importance of implementing strong patient identification measures in the context of telemedicine.

According to some physicians who presented during the Telemedicine Listening Sessions, identity verification of telemedicine patients is currently a typical practice and constitutes a component of good care.

Furthermore, the photographic record provides a clear link between the patient's identity and the telemedicine encounter, supporting accurate recordkeeping under the

Special Registration

framework.

Telemedicine Listening Sessions: Lori Uscher-Pines (RAND Corporation), 131:15-19 (Sept. 12, 2023); Bruce Bassi, M.D., 29:18-30:3 (Sept. 13, 2023); Dr. Phillip Moore (Gaudenzia), 85:10-16, 86:14-87:8 (Sept. 13, 2023); and Dan Golden (East Coast Telepsychiatry), 218:9-14 (Sept. 13, 2023).

Telemedicine Listening Sessions: Dr. Shabana Khan (American Psychiatric Association and American Academy of Child and Adolescent Psychiatry), 33:20-34:5, 43:9-19 (Sept. 12, 2023); Dr. Brian Clear (Bicycle Health), 77:13-22 (Sept. 12, 2023); Telemedicine Listening Sessions: Lori Uscher-Pines (RAND Corporation), 131:15-19 (Sept. 12, 2023); Bruce Bassi, M.D., 29:18-30:3 (Sept. 13, 2023); Dr. Phillip Moore (Gaudenzia), 85:10-16, 86:14-87:8 (Sept. 13, 2023); and Dan Golden (East Coast Telepsychiatry), 218:9-14 (Sept. 13, 2023).

See

Telemedicine Listening Sessions, Bruce Bassi, M.D., 31:12-20 (Sept. 13, 2023).

2. Special Registration Telemedicine Encounter Record

For every telemedicine encounter resulting in a

special registration prescription,

proposed 21 CFR 1304.04(j) would require that

clinician special registrants

maintain a record of the date and time of the telemedicine encounter, the address of the patient during the telemedicine encounter, and the home address of the patient. Like patient verification photographic records, the

clinician special registrant

would be required to maintain

Special Registration

telemedicine encounter records for a minimum of two (2) years from the date of the telemedicine encounter. The proposed

Special Registration

telemedicine encounter record provides an additional layer of verification for the telemedicine encounter, detailed documentation that can be referenced by the

clinician special registrant

in the future and helps ensure that the patient is located in a state in which the

clinician special registrant

is authorized to prescribe controlled substances under the proposed

Special Registration

framework.

3. Credential Verification and Conduct-Related Documentation

Proposed 21 CFR 1304.04(k) would require

platform special registrants

to maintain records related to

clinician special registrants

with whom they enter and maintain a

covered platform relationship,

including:

(1) verification of the

clinician special registrant

credentials, including but not limited to records on education, training, board or specialty certifications, and their

Special Registration

number and

State Telemedicine Registration

number(s); (2) the employment contract and any other contract between the

platform special registrant

and the

clinician special registrant;

and (3) any disciplinary actions or sanctions, or documentation of complaints, disputes, or incidents involving the

practice of telemedicine

. The

platform special registrant

would be required to maintain and update the credential verification and conduct-related records for a minimum of every two (2) years, which should be readily available for inspection by DEA.

Proposed 21 CFR 1300.04 would define a

covered platform relationship

to mean “the formal association between the online telemedicine platform, in its capacity as a

platform practitioner,

and the

clinician practitioner

it directly employs, contracts with, or is otherwise professionally affiliated with to introduce or facilitate connections between patients seeking remote medical consultations and the

clinician practitioner,

via an audio-video telecommunications system, for the diagnosis, treatment, and prescription of controlled substances.”

This proposed requirement is intended to address DEA's concerns regarding the adequacy of the screening of the prescribers utilizing the services of the

covered online telemedicine platforms

as discussed above. By mandating the verification and documentation of

clinician registrants'

qualifications and credentials, these records should serve as evidence of thorough screening processes by the

platform special registrants,

helping to ensure that only qualified and vetted

clinician practitioners

are practicing telemedicine under the

Special Registration

framework and reducing the risk of improper remote prescribing of controlled substances. Furthermore, by requiring that

platform special registrants

maintain such records, they are compelled to assume responsibility for the conduct and prescribing practices of the

clinician special registrants

whose telemedicine prescribing is facilitated by their platform.

4. Centralized Recordkeeping at the

Special Registered Location

Proposed 21 CFR 1304.04(l) mandates that records arising from telemedicine encounters under the

Special Registration

framework be kept at the

special registered location.

Given the nationwide reach of telemedicine—where a

special registrant

could serve patients in any state—it would pose an unreasonable administrative burden to require the

special registrant

to maintain records in every state where telemedicine patients are located. By consolidating these records, DEA investigations are more efficient, enhancing the detection of diversion patterns, which is vital for preventing the diversion and misuse of controlled substances. This approach enhances public safety while ensuring a practical burden for practitioners. Furthermore, this proposed regulation keeps pace with modern recordkeeping practices, as the majority of healthcare providers already maintain electronic records, which can be easily centralized and accessed when required.

5. Pharmacy Reporting of

Special Registration Prescription

Data

Proposed 21 CFR 1304.60 would require that a pharmacy report aggregate data, within the first seven (7) days of the start of every month, for the

special registration prescriptions

filled during the preceding month for each Schedule II controlled substance and certain Schedule III-V controlled substances, including Ketamine, Tramadol, and any depressants that constitute a benzodiazepine (including their salts, isomers, and salt of isomers).

For each

of these controlled substances, the pharmacy would provide the following information, organized by the different

State Telemedicine Registration numbers

of the

individual special registrants

who prescribed the controlled substance, and organized by the National Drug Code (NDC) for each formulation of the controlled substance dispensed: the number of prescriptions filled, the volume of the controlled substance dispensed, and the number of patients prescribed the controlled substance. A NDC is a unique, 10-digit three-segment number that serves as a universal product identifier for human drugs, including controlled substances. It is used by drug establishments, such as manufacturers and distributors, to report all drugs made, prepared, propagated, compounded or processed for sale in the U.S. to the Food and Drug Administration (FDA).

At this time, Schedule III-V controlled substances subject to this proposed requirement under 21 CFR 1304.60 are limited to those specifically identified. However, additional Schedule III-V controlled substances may be included in the future via regulation based on trends in diversion and misuse.

DEA has identified 36 depressants that constitute a benzodiazepine Scheduled in 21 CFR 1308.14(c) at the time of this publication.

National Drug Code Directory, U.S. Food & Drug Administration (FDA) (July 22,2022) (

https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory

Requiring timely collection and reporting of aggregate patient-anonymized prescription data ensures that DEA has current information on the prescribing of controlled substances via telemedicine, vital for protecting public health and safety, especially amid the national opioid overdose epidemic. Following the COVID-19 PHE, the opioid overdose epidemic has only worsened. According to the Centers for Disease Control and Prevention (CDC), the “number of people who died from a drug overdose in 2021 was over six times the number in 1999. The number of drug overdose deaths increased more than 16% from 2020 to 2021. Over 75% of the nearly 107,000 drug overdose deaths in 2021 involved an opioid.”

Understanding the Opioid Overdose Epidemic,

Centers for Disease Control and Prevention (CDC) (Aug. 8, 2023),

https://www.cdc.gov/opioids/basics/epidemic.html

While the opioid overdose epidemic has, in recent years, been largely fueled by illicitly manufactured

fentanyl,

a synthetic opioid, the diversion of prescribed opioids exacerbates the opioid crisis by increasing the overall opioid supply available on the illicit market. Proposed 21 CFR 1304.60 would arm DEA with the data necessary to timely intervene in cases of diversion or other acts in violation of the law. Recognizing the importance of data to combat diversion, various stakeholders speaking at the Telemedicine Listening Sessions—many of whom were practitioners—advocated for DEA to collect prescription data to help identify potential exploitative practices.

One physician said, “I urge DEA to design any new process to improve [its] ability to oversee and audit prescribing patterns and to intervene when exploitative practice is identified. . . .”

Telemedicine Listening Sessions, Robert Krayn (Talkiatry), 26:4-21 (Sept. 12, 2023); Dr. Shabana Khan (American Psychiatric Association and American Academy of Child and Adolescent Psychiatry), 37:2-11 (Sept. 12, 2023); Dr. Brian Clear (Bicycle Health), 79:8-13, 87:3-8 (Sept. 12, 2023); Chris Adamec (Alliance for Connected Care), 143-18-144:11, 146:5-8 (Sept. 12, 2023); Kevin Duane, PharmD, 207:3-9, 213:13-214:9 (Sept. 12, 2023); Felicia Baily (Nurse Practitioner, Avaesen Healthcare), 17:25-18:21 (Sept. 13, 2023); and John Heaphy (New York Dept. of Health), 78:25-79:6 (Sept. 13, 2023).

Telemedicine Listening Sessions, Dr. Brian Clear (Bicycle Health), 79:8-13 (Sept. 12, 2023).

The aggregation of prescription data would also allow DEA to employ advanced data analytics to further combat diversion. With such data, for example, DEA could detect outliers, irregular prescription volumes, and abnormal geographic concentrations of controlled substances. As identified by the Government Accountability Office (GAO) in its 2020 recommendations to DEA, which encouraged the enhanced utilization of data analytics to identify problematic patterns and trends to combat the opioid epidemic, “data-analytics activities can include a variety of techniques to prevent and detect diversion, including data matching and data mining. Data matching is the largescale comparison of records and files to detect errors or incorrect information. It can be used to verify information provided by recipients or detect unreported changes. Data mining is the use of automated computer algorithms to detect patterns, including those that are otherwise not obvious, correlations, or anomalies within large data sets indicative of potential diversion.”

At the Telemedicine Listening Sessions, similar recommendations to those of the GAO were echoed.

100

Various stakeholders advocated for the leveraging of data analytics as a tool to be used by DEA to address bad actors or exploitative practices.

101

Drug Control: Actions Needed to Ensure Usefulness of Data on Suspicious Opioid Orders,

U.S. Gen. Accounting Office, GAO-20-118, (Jan. 29, 2020),),

https://www.gao.gov/products/gao-20-118#summary_recommend

100

Telemedicine Listening Sessions, Dr. Shabana Khan (American Psychiatric Association and American Academy of Child and Adolescent Psychiatry), 37:18-23 (Sept. 12, 2023); Dr. Brian Clear (Bicycle Health), 79:8-13 (Sept. 12, 2023); and Laura Jantos (Healthcare Technology and Digital Healthcare Management Consultant), 14:25-15:21 (Sept. 13, 2023).

101

Id.

Data analytics could help recognize patterns in how controlled substances are combined to provide DEA with critical information about emerging trends in polysubstance abuse.

102

Recent examples highlight the dangers of such combinations, underscoring the need for proactive measures. Benzodiazepines, Schedule IV depressants, have been used to amplify the effect of opioids, especially when injected.

103

The combination of opioids and benzodiazepines can have dire consequences, as their use together increases the risk of overdose as both drugs cause sedation and suppress breathing.

104

According to one study, overdose death rates among patients taking both drugs was 10 times higher than among those only receiving opioids.

105

By staying informed about emerging drug use trends, particularly polysubstance abuse, DEA can take proactive measures to prevent these trends from evolving into widespread problems. This information not only aids in prevention but could also guide DEA in strategically directing resources and investigative efforts to ensure the most effective responses to emerging challenges.

102

Centers for Disease Control and Prevention (CDC).

What is Polysubstance Use?

(February 23, 2022) (Available:

https://www.cdc.gov/stopoverdose/polysubstance-use/index.html

103

Jones JD, Mogali S, Comer SD.

Polydrug abuse: a review of opioid and benzodiazepine combination use

. Drug Alcohol Depend. 2012 Sep 1;125(1-2):8-18. doi: 10.1016/j.drugalcdep.2012.07.004. Epub 2012 Aug 2. PMID: 22857878; PMCID: PMC3454351 (Available:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3454351/

104

National Institute on Drug Abuse (NIDA).

Benzodiazepines and Opioids

. (November 7, 2022), Available:

https://nida.nih.gov/research-topics/opioids/benzodiazepines-opioids

105

Dasgupta N, Funk MJ, Proescholdbell S, Hirsch A, Ribisl KM, Marshall S.

Cohort Study of the Impact of High-Dose Opioid Analgesics on Overdose Mortality

. Pain Med. 2016 Jan;17(1):85-98. doi: 10.1111/pme.12907. Erratum in: Pain Med. 2016 Apr;17(4):797-8. PMID: 26333030,

https://pubmed.ncbi.nlm.nih.gov/26333030/

Lastly, DEA could use the aggregated data to make more informed, evidence-based policy decisions. For instance, DEA could timely monitor controlled substance prescription patterns and demand indicators to make informed quota decisions to prevent or mitigate shortages and ensure a steady and reliable supply of controlled substances for legitimate medical purposes. The data could also be used to better retrospectively assess the impact of DEA's policy positions and promulgated

regulations.

106

For example, DEA could use the prescription data to evaluate: patient outcomes associated with

special registration prescriptions

; the impact of the proposed

Special Registration

regulations on patient access to controlled substances (especially in remote or rural areas); the efficacy of the proposed

Special Registration

regulations on preventing and detecting diversion associated with remote prescribing; and trends or changes to telemedicine prescription practices that might necessitate regulatory reforms.

106

See

Administrative Conference of the United States (ACUS),

Administrative Conference Recommendation 2021-2: Periodic Retrospective Review

(June 17, 2021) (Available:

https://www.acus.gov/document/periodic-retrospective-review

It should be emphasized that the prescription data reporting would be aggregated and patient-anonymized, and will not be shared with persons or entities outside of DEA. Like all data provided to, and handled by, DEA, the security and privacy of such data will be handled with the highest standards of security and privacy. All data transmitted to and stored by DEA is encrypted, including data transmitted between external systems and internal databases. Furthermore, all data transmitted from registrants to DEA is additionally protected by Department of Justice firewalls and network monitoring. Access to the data is limited to certain authorized persons, employed or contracted by DEA. External user access to applications receiving and providing data require a unique username and a strong, complex password, internal users of the data are vetted by DEA and its Diversion Control Division's security and privacy processes, and access is restricted according to a need-to-know-basis.

6. Annual Special Registrant Reporting of Special Registration Prescription Data

Proposed 21 CFR 1304.61 would require that

individual special registrants

and

platform special registrants

report annual data on the total number of new patients in each state for which they issued at least one

special registration prescription

for a Schedule II controlled substance or certain Schedule III-V controlled substances, including Ketamine, Tramadol, and any depressant constituting a benzodiazepine; the total number of

special registration prescriptions

for Schedule II controlled substances issued by the

special registrant,

in aggregate and across all states; and the total number of

special registration prescriptions

for certain Schedule III-V controlled substances, including Ketamine, Tramadol, and any depressant constituting a benzodiazepines (including their salts, isomers, and salt of isomers), which were issued by the

special registrant,

in aggregate and across all states.

This proposed reporting requirement would provide DEA with necessary data to proactively monitor for concerning trends that may signal the existence of digital pill mills exploiting the proposed

special registration

framework to provide patients with medically unnecessary controlled substances.

107

Data on new patients and distribution of Schedule IIs and certain Schedule III-V controlled substances on an annual basis would allow DEA to assess prescribing behaviors of controlled substances, identify spikes and anomalies in prescription volume, and take timely action against suspicious activity. At this time, Schedule III-V controlled substances subject to this proposed requirement under 21 CFR 1304.61 are limited to those specifically identified. However, additional Schedule III-V controlled substances may be included in the future via regulation based on trends in diversion and misuse.

107

Stevens, Morgan.

Click Here for Adderall: Fixing Telehealth Advertising and Services to Prevent Stimulant Misuse,

Center for Data Innovation (Dec. 5, 2022),

https://www2.datainnovation.org/2022-telehealth-stimulant-abuse.pdf

D. Regulatory Definitions Under 21 CFR part 1300

This last section provides an overview of proposed regulatory definitions and revisions to 21 CFR part 1300. These proposed definitions are intended to provide clarity as to the authorities and obligations of

special registrants

under the registration requirements (21 CFR 1301), prescription requirements (21 CFR 1306), and the recordkeeping and reporting requirements (21 CFR 1304). The proposed amendments offer definitions for the different, relevant registrations under the

Special Registration

framework, including the:

Telemedicine Prescribing Registration, Advanced Telemedicine Prescribing Registration,

Telemedicine Platform Registration, State Telemedicine Registration,

and

special registered location

. The core aspects of these proposed definitions have largely been addressed in the preceding sections, requiring minimal discussion of many of them here.

That said, the proposed term and definition of a

covered online telemedicine platform

warrants further discussion. A

covered online telemedicine platform

means an entity that facilitates connections between patients and

clinician practitioners,

via an

audio-video telecommunications system,

for the diagnosis and treatment of patients that may result in the prescription of controlled substances, but is not a hospital, clinic,

local in-person medical practice,

or insurance provider, and meets one or more of the following criteria:

(1) the entity explicitly promotes or advertises the prescribing of controlled substances through the platform;

(2) the entity has financial interests, whether direct incentives or otherwise, tied to the volume or types of controlled substance prescriptions issued through the platform, including but not limited to, ownership interest in pharmacies used to fill patients' prescriptions, or rebates from those pharmacies;

(3) the entity exerts control or influence on clinical decision-making processes or prescribing related to controlled substances, including, but not limited to: prescribing guidelines or protocols for

clinician practitioners

employed or contracted by the platform; consideration of

clinician practitioner

prescribing rates in the entity's hiring, retention, or compensation decisions; imposing explicit or de facto prescribing quotas; directing patients to preferred pharmacies; and/or

(4) the entity has control or custody of the prescriptions or medical records of patients who are prescribed controlled substances through the platform.

When any one of the four factors are present, it solidifies the platform's role as an integral intermediary in the remote dispensing of controlled substances. The proposed definition and criteria are intended to provide a practical and clear framework for identifying when a DTC online telemedicine platform's conduct qualifies them as a

covered online telemedicine platform,

mandating registration as a dispenser with DEA. As proposed, this definition is intended to limit the

Special Registration

requirements only to those DTC online telemedicine platforms that play a substantial and integral role as intermediaries in the remote dispensing of controlled substances.

Under the first criterion, when an entity explicitly promotes or advertises the prescribing of controlled substances through the platform, it is directly influencing patient behavior and decision-making. This targeted promotion guides patients to seek medical consultations and prescriptions for controlled substances through the platform, effectively influencing the

demand and supply of this service. This active role in at

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