`[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Proposed Rules]
[Pages 6541-6598]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01099]



  Federal Register / Vol. 90 , No. 11 / Friday, January 17, 2025 / 
Proposed Rules  

[[Page 6541]]


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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.

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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
    a. Telemedicine Prescribing Registration Eligibility
    b. Advanced Telemedicine Prescribing Registration Eligibility
    c. Telemedicine Platform Registration Eligibility
    2. Ancillary Registrations: State Telemedicine Registrations
    3. Special Registration Application Process
    a. 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)
    4. Special Registration Actions
    a. Approvals and Denials of Special Registration Applications
    b. Suspension and Revocations of Special Registrations
    B. 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
    2. Special Registration Telemedicine Encounter Records
    3. Credentials Verification and Conduct-Related Documentation 
Records
    4. Centralized Recordkeeping at the Special Registered Location

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    5. Pharmacy and Special Registrant Reporting of Special 
Registration Prescription Data
    6. 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 \1\ be issued as a ``valid 
prescription.'' \2\ Generally, a valid prescription requires, at a 
minimum, at least one ``in-person medical evaluation,'' \3\ which is 
issued for a legitimate medical purpose in the usual course of 
professional practice.\4\ 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.'' \5\
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    \1\ 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.
    \2\ 21 U.S.C. 829(e)(1).
    \3\ 21 U.S.C. 829(e)(2)(B)(i).
    \4\ 21 U.S.C. 829(e)(2)(A)(i).
    \5\ 21 U.S.C. 829(e)(3)(A).
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    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.\6\ 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.
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    \6\ 21 U.S.C. 802(54).
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    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.\7\ To satisfy the

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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.
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    \7\ 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.''
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    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,\8\ 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.\9\
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    \8\ 21 U.S.C. 802(54)(E).
    \9\ See Appendix A for Chart: Do I Need a Special Registration 
for Telemedicine?
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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.\10\ 
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.\11\
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    \10\ ``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).
    \11\ 21 U.S.C. 871(b), 958(f).
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    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

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Cosmetic Act may be . . . dispensed by means of the internet without a 
valid prescription,'' \12\ 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.'' 
\13\ Section 829(e), however, provides an exception to this in-person 
medical evaluation requirement where the practitioner is ``engaged in 
the practice of telemedicine.'' \14\
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    \12\ 21 U.S.C. 829(e)(1).
    \13\ 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.
    \14\ Id. 829(e)(3)(A).
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    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) \15\ 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 \16\ 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.
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    \15\ 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.
    \16\ 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.
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    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; \17\ (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.\18\
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    \17\ 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.
    \18\ 21 U.S.C. 802(54).
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    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

[[Page 6545]]

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); \19\ and
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    \19\ 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.
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     A March 31, 2020 ``Dear Registrant'' letter signed by 
Thomas W. Prevoznik, DEA's then-Deputy Assistant Administrator, 
Diversion Control Division (the Prevoznik Letter).\20\
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    \20\ 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(Fina
l)%20+Esign.pdf.
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    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'') \21\ and Expansion of Induction of 
Buprenorphine via Telemedicine Encounter (the ``Buprenorphine 
NPRM''),\22\ 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.
---------------------------------------------------------------------------

    \21\ 88 FR 12875 (Mar. 1, 2023).
    \22\ 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.\23\ 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.
---------------------------------------------------------------------------

    \23\ 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.\24\ 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.
---------------------------------------------------------------------------

    \24\ 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

[[Page 6546]]

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.\25\ 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.
---------------------------------------------------------------------------

    \25\ 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.\26\ 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.\27\
---------------------------------------------------------------------------

    \26\ 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.
    \27\ 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.\28\ 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 \29\ 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.\30\
---------------------------------------------------------------------------

    \28\ 21 U.S.C. 831(h)(1)(B).
    \29\ 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 
Sec.  1300.04 of this chapter.
    \30\ 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.' '' \31\ 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.\32\
---------------------------------------------------------------------------

    \31\ Dewey C. MacKay, 75 FR 49956, 49973 (2010), aff'd, MacKay 
v. DEA, 664 F.3d 808 (10th Cir. 2011).
    \32\ 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

[[Page 6547]]

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.'' \33\ 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.
---------------------------------------------------------------------------

    \33\ 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.'' \34\ 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.\35\
---------------------------------------------------------------------------

    \34\ 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.
    \35\ 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.\36\
---------------------------------------------------------------------------

    \36\ 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-

[[Page 6548]]

pharmacist practitioners \37\ under the Controlled Substances Act and 
its regulations.
---------------------------------------------------------------------------

    \37\ 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.\38\ 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.\39\ 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.
---------------------------------------------------------------------------

    \38\ 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.
    \39\ 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.\40\ 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.
---------------------------------------------------------------------------

    \40\ Ryan Haight Online Pharmacy Consumer Protection Act of 
2008, Public Law 110-425, 122 Stat. 4820, Sec.  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.\41\ 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.\42\
---------------------------------------------------------------------------

    \41\ 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.
    \42\ 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.''
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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.

[[Page 6549]]

1. Three Types of Special Registration; Registrant Eligibility
    The proposed requirements for the Special Registration \43\ 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.\44\ 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.\45\ 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.
---------------------------------------------------------------------------

    \43\ Proposed 21 CFR 1301.11.
    \44\ 21 U.S.C. 831(h)(1)(A).
    \45\ 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.\46\ 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,\47\ even though such substances have 
higher potential for abuse and dependence.\48\ 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.\49\
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    \46\ Proposed 21 CFR 1301.11(c)(2).
    \47\ Proposed 21 CFR 1301.11(c)(3).
    \48\ See 21 U.S.C. 812(b)(2), (3).
    \49\ Proposed 21 CFR 1301.11(c)(4).
---------------------------------------------------------------------------

    Under proposed Sec.  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 Sec.  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 Sec.  1301.11(c)(1)(i) makes it clear that those officials 
for whom the requirement of registration to prescribe is generally 
waived under Sec.  1301.23(a) of this chapter must still obtain a 
Telemedicine Prescribing Registration or Advance Telemedicine 
Prescribing Registration before issuing special registration 
prescriptions.\50\ 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.
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    \50\ 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.''
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a. Telemedicine Prescribing Registration (Schedules III-V) Clinician 
Practitioners Eligibility
    To be eligible for the Telemedicine Prescribing Registration under 
proposed Sec.  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 Sec.  1301.11(c)(3), physicians and mid-
level practitioners, as 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; \51\
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    \51\ 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.

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[[Page 6550]]

    (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.\52\ 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.\53\ 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.
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    \52\ 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).
    \53\ 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.\54\ 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.
---------------------------------------------------------------------------

    \54\ 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 Sec.  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'' \55\ 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.
---------------------------------------------------------------------------

    \55\ 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.
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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

[[Page 6551]]

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 Sec.  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 or 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),\56\ or (2) the clinician special registrant is an 
employee or contractor of the VA.\57\
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    \56\ 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.''
    \57\ 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.\58\ 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.\59\
---------------------------------------------------------------------------

    \58\ 21 U.S.C. 802(54)(A)(ii)(III)(bb).
    \59\ 21 U.S.C. 831(h)(1)(B)(i)-(ii).
---------------------------------------------------------------------------

    While proposed Sec.  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.\60\
---------------------------------------------------------------------------

    \60\ 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, or 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.\61\ The fee for the State Telemedicine 
Registration for clinician practitioners is discounted to account for 
the expected

[[Page 6552]]

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.\62\
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    \61\ 21 CFR 1301.21 exempts certain clinician practitioner 
applicants from payment of application fees for registration, 
including for Special Registrations and State Telemedicine 
Registrations.
    \62\ 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).
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b. Supplemental Requirements on Special Registration Application (Form 
224S)
    Special Registered Location. Pursuant to proposed Sec.  
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.\63\ Such centralized 
recordkeeping would allow DEA to more efficiently review records and 
ensure that prescriptions are being issued in accordance with DEA 
regulations. Proposed Sec.  1301.13(k)(1) would provide an exemption 
for applicants who are exempted from the State Telemedicine 
Registration requirement under proposed Sec.  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.
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    \63\ 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 Sec.  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 Sec.  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.\64\ Second, proposed Sec.  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.
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    \64\ 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 Sec.  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 
or 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 Sec.  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.

[[Page 6553]]

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 Sec.  
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,\65\ and, if requested by the applicant, hold a hearing on the 
application pursuant to 21 CFR 1301.31 for Special Registration 
Applications.
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    \65\ 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.
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    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, or 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.\66\ 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.
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    \66\ 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.\67\ 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

[[Page 6554]]

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.\68\ 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.\69\ 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.
---------------------------------------------------------------------------

    \67\ Electronic Prescriptions for Controlled Substances, 75 FR 
16236 (March 31, 2010).
    \68\ EPCS Mandates: Ultimate Guide to 2023 Deadlines  
RXNT (Available: https://www.rxnt.com/epcs-mandates/).
    \69\ 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.\70\
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    \70\ 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.\71\ By observing a

[[Page 6555]]

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,\72\ 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.\73\ At the 
Telemedicine Listening Sessions, various speakers advocated for the use 
of audio-video telemedicine specifically.\74\ 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.'' \75\
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    \71\ 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).
    \72\ 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.
    \73\ 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.
    \74\ 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).
    \75\ 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.\76\
---------------------------------------------------------------------------

    \76\ 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.\77\
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    \77\ 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.\78\ 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.
---------------------------------------------------------------------------

    \78\ 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.\79\ 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.\80\ Access to buprenorphine decreases the risk of overdosing,\81\ 
and increasing access to buprenorphine after a drug overdose has also 
been associated with a reduced risk of death.\82\ This allowance 
acknowledges the specific challenges faced by OUD patients and the 
importance of ensuring consistent therapeutic relationships with 
limited interruptions.
---------------------------------------------------------------------------

    \79\ 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/.
    \80\ 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.
    \81\ 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.
    \82\ 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

[[Page 6556]]

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.\83\ 
Another presenter said that drugs like suboxone and buprenorphine, 
prescribed to treat OUD, are used as a ``currency'' to purchase other 
drugs like methamphetamines, and that in his community, ``if 
methamphetamine is involved, you can pretty much be assured the 
diversion of buprenorphine is involved.'' \84\
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    \83\ Telemedicine Listening Sessions, Daniel Reck (Matclinics), 
104:3-9. (Sept. 12, 2023).
    \84\ 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.\85\ 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.
---------------------------------------------------------------------------

    \85\ 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.\86\ 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.
---------------------------------------------------------------------------

    \86\ 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, a 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.\87\ 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.
---------------------------------------------------------------------------

    \87\ 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

[[Page 6557]]

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.\88\ 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)).\89\ 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).
---------------------------------------------------------------------------

    \88\ 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.
    \89\ 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 by 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,

[[Page 6558]]

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.\90\ 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.\91\ 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.\92\
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    \90\ 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).
    \91\ 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).
    \92\ See Telemedicine Listening Sessions, Bruce Bassi, M.D., 
31:12-20 (Sept. 13, 2023).
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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: \93\ (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.
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    \93\ 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.''
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    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).\94\ For each

[[Page 6559]]

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).\95\ 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.
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    \94\ DEA has identified 36 depressants that constitute a 
benzodiazepine Scheduled in 21 CFR 1308.14(c) at the time of this 
publication.
    \95\ 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.'' \96\
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    \96\ 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.\97\ 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. . . .'' \98\
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    \97\ 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).
    \98\ 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.'' \99\ 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\
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    \99\ 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.
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    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.
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    \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

[[Page 6560]]

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.
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    \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).
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    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

[[Page 6561]]

demand and supply of this service. This active role in attracting and 
managing patient flow makes the platform more involved as an integral 
intermediary in the remote prescribing of controlled substances. Under 
the second criterion, when an entity has financial interests tied to 
the volume or types of controlled substances prescriptions issued 
through the platform, the platform's role extends beyond mere 
facilitation--it becomes a key player that directly affects the flow 
and distribution of controlled substances. The financial ties ensure 
that the platform's operations are closely linked to the outcome of 
prescription activities, making it an integral intermediary in the 
process of remote prescribing of controlled substances.
    Under the third criterion, when an 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, imposing explicit or de facto prescribing 
quotas, or directing patients to preferred pharmacies, it plays a 
direct and active role in the decision-making processes that affect 
patient care and the distribution of controlled substances. The 
platform becomes an essential link in the chain between the clinician 
practitioner and the patient, making it an integral intermediary in the 
process of remote prescribing of controlled substances. Under the 
fourth and last criterion, when an entity has control or custody of the 
prescriptions or medical records of patients who are prescribed 
controlled substances through the platform, it has significant control 
over sensitive and regulated information, actively involving the 
platform in the handling and processing of controlled substances. 
Moreover, control or custody of such information allows a platform to 
influence patient treatment plans, underscoring their position as an 
intermediary, and thus dispenser, in the process of remote prescribing 
of controlled substances.
    It is important to clarify that ownership and operation of the 
online or digital system or platform on which the virtual visit takes 
places are not mandatory criteria within the proposed definition of a 
covered online telemedicine platform. Similarly, an entity solely 
operating a platform or system that merely provides the technological 
service or conduit for a telemedicine encounter to occur, without the 
presence of one of the additional four factors, would not constitute a 
covered online telemedicine platform. As discussed above, the 
definition is also drafted to exclude 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.
    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 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.
    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.
    Turning elsewhere, DEA is incorporating CMS's current definitions 
and standards for the terms hospice care and palliative care.\108\ DEA 
acknowledges that its core expertise and mission revolve around 
combating the diversion of controlled substances, and therefore is 
leveraging the medical expertise of CMS by adopting its healthcare 
standards as to these terms. Lastly, the rulemaking rule proposes to 
revise the DEA regulatory definition of ``practice of telemedicine'' to 
mean practice in accordance with applicable federal and state laws by a 
practitioner (other than a pharmacist) who is at a remote location from 
the patient and communicates with the patient, or health care 
professional who is treating the patient, using a telecommunications 
system defined in 42 CFR 410.78(a)(3), which practice falls within a 
category specified in the definition.\109\
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    \108\ See 42 CFR 418.3.
    \109\ Proposed 21 CFR 1300.04. The current regulatory 
definition, 21 CFR 1300.04, initially implemented the Ryan Haight 
Act's statutory definition by repeating the statutory provision and 
requiring the use of a ``telecommunications system referred to in 
section 1834(m) of the Social Security Act'' [codified at 42 U.S.C. 
1395m(m)].
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E. Request for Comments

    With respect to the proposed rule, DEA invites comments regarding 
the need for any clarifications or suggested modifications to the 
proposed regulations, which are consistent with the public health and 
safety. The public's input and insights are instrumental in achieving 
the appropriate balance between expanding access to care and 
implementing the necessary safeguards to prevent diversion of 
controlled substances effectively. In particular, DEA seeks the 
public's input on the newly introduced Special Registrations 
(Telemedicine Prescribing Registration, Advanced Telemedicine 
Prescribing Registration, and Telemedicine Platform Registration), and 
the State Telemedicine Registrations. Again, DEA recognizes the broad 
nature of the proposed requirements, and highly encourages the public 
to provide input on appropriate implementation timelines, or on-ramps 
for phased or gradual adoption, to help ensure a smoother transition 
when the final rule takes effect. Practitioners, pharmacies, and 
industry are encouraged to provide their input on the time necessary to 
operationalize the proposed requirements.
    Furthermore, DEA is considering the inclusion of a severability 
clause in the final rule. Under such a clause, if any specific 
provision of the rule is found to be invalid or unenforceable by a 
court, the remaining provisions would continue to be operative and 
enforceable. We encourage public comments on the inclusion of such a 
clause, as well as whether any particular provisions of the proposed 
rule are especially integral to its overall implementation. All public 
insight, including responsive data, as to the effectiveness or 
appropriateness of the proposed safeguards is also encouraged. However, 
the public is asked to refrain from commenting on provisions that are 
simply republished existing regulatory definitions. These are included 
to provide context to the newly proposed definitions and to reduce 
editorial resources required for publishing the proposed rule.

[[Page 6562]]

Appendices:
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V. Regulatory Analyses

Executive Orders 12866, 13563, and 14094 (Regulatory Review)

    DEA has determined that this rulemaking is a ``significant 
regulatory action'' under section 3(f) of Executive Order (E.O.) 12866, 
Regulatory Planning and Review and is also a section 3(f)(1) 
significant action. Accordingly, this proposed rule has been submitted 
to the Office of Management and Budget (OMB) for review. This proposed 
rule has been drafted and reviewed in accordance with E.O. 12866, 
``Regulatory Planning and Review,'' section 1(b), Principles of 
Regulation; E.O. 13563, ``Improving Regulation and Regulatory Review,'' 
section 1(b), General Principles of Regulation; and E.O. 14094, 
``Modernizing Regulatory Review.''
    Due to many uncertainties, DEA made a range of estimates: a low 
estimate, a moderate (primary) estimate, and a high estimate. Based on 
the moderate (primary) estimate, DEA projects that this proposed rule 
will result in a total annualized cost of $16 million, a total 
annualized cost savings of $23 million, for a net annualized cost 
savings of $7 million. The low estimate results in a total annualized 
cost of $0.60 million, a total annualized cost savings of $0.85 
million, for a net annualized cost savings of $0.25 million. The high 
estimate results in a total annualized cost of $86 million, a total 
annualized cost savings of $122 million, for a net annualized cost 
savings of $36 million. Additionally, the proposed rule is estimated to 
increase annualized transfers (registration fees) to the federal 
government by $0.90 million, $24 million, and $128 million per year, 
for the low, moderate (primary), and high estimates, respectively. Fees 
paid to the federal government are considered transfer payments and not 
costs.\110\ The full analysis of cost savings, costs, transfers, and 
benefits is provided below.
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    \110\ OMB Circular A-4.

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[[Page 6565]]

Overview

I. Regulatory Alternatives Considered
II. Patient Costs, Cost Savings, and Benefits
    a. Patient's Cost of Time per Practitioner Visit
    b. Patient's Cost of Travel per Practitioner Visit
    c. Total Number of Telemedicine Visits
    i. Total Number of Telemedicine Visits Under the Current 
Telemedicine Rate
    ii. Forecasted Total Numbers of Telemedicine Visits
    d. Total Patient Cost Savings
    e. Patient Benefit: Increased Access to Care
III. Practitioner and Mid-Level Practitioners (``MLP'') Costs, Cost 
Savings, and Transfers
    A. Number of Conventional Registrations, Special Registrations, 
and State Telemedicine Registrations
    B. Practitioner and MLP Cost To Apply for Special Registration
    C. Practitioner and MLP Cost To Report to DEA
    D. Practitioner and MLP Cost To Check PDMP per Visit
    E. Practitioner and MLP Total Costs; Cost Savings
    F. Practitioner and MLP Transfers
    G. Summary of Practitioner Costs, Cost Savings, Benefits, and 
Transfers
IV. Pharmacy Costs
V. Healthcare System Costs and Cost Savings
VI. State Costs
VII. Diversion
VIII. Summary of Economic Impact

I. Regulatory Alternatives Considered

    DEA considered three alternatives, including the selected 
alternative: (1) finalizing the proposed March 2023 General 
Telemedicine NPRM and Buprenorphine NPRM; (2) an alternative that would 
allow the prescribing of Schedules III-V controlled substances under a 
single Special Registration for Telemedicine pursuant to 21 U.S.C. 
802(54)(E) and 831(h); and (3) the selected alternative.
    First, DEA considered promulgating final rules based on the 
proposed March 2023 General Telemedicine NPRM and Buprenorphine NPRM 
pursuant to 21 U.S.C. 802(54)(G). The proposed General Telemedicine 
NPRM would have allowed for an initial prescription of non-narcotic 
Schedules III-V controlled substances for no more than a 30-day supply 
in instances where the patient has never had an in-person medical 
evaluation, and additional prescriptions beyond the initial 30-day 
prescription would require that the patient undergo an in-person 
medical evaluation. The proposed General Telemedicine NPRM generally 
would have required that a patient undergo an initial in-person medical 
evaluation prior to the prescription of Schedule II controlled 
substances, and Schedule III-V narcotic controlled substances (with the 
exception of buprenorphine for opioid use disorder (``OUD'') 
treatment), unless there was a qualifying referral.
    Generally, the Buprenorphine NPRM would have allowed practitioners 
to prescribe buprenorphine for the induction of OUD treatment for no 
more than a 30-day supply through audio-only telemedicine. To obtain an 
additional supply of buprenorphine however, the patient would have to 
undergo an in-person medical evaluation within 30 days of the induction 
of the OUD treatment. Ultimately, DEA determined that final rules of 
the proposed regulations would have been potentially too burdensome on 
practitioners and patients, leading to reduced access to care.
    The second alternative considered by DEA would have allowed 
practitioners--irrespective of their medical specialty or the patients 
they treat--to prescribe Schedule III-V controlled substances under a 
single Special Registration for Telemedicine pursuant to 21 U.S.C. 
802(54)(E) and 831(h). Under this alternative, practitioners would not 
be authorized to prescribe Schedule II controlled substances. While 
this alternative could have established a more streamlined Special 
Registration framework, it would not take into consideration the 
diverse legitimate needs that practitioners may have to prescribe other 
controlled substances through telemedicine based on their medical 
specialties or the patients they serve. Additionally, it does not 
consider the fact that certain practitioners possess the necessary 
qualifications to prescribe Schedule II controlled substances through 
telemedicine, despite the heightened risk of abuse associated with 
Schedule II controlled substances. Consequently, DEA opted against this 
alternative.
    Finally, DEA is proposing the selected alternative, which would not 
require an in-person medical evaluation such as required under the 
first alternative and would allow certain qualified practitioners who 
demonstrate a legitimate need to prescribe Schedule II controlled 
substances through telemedicine unlike the second alternative. The 
selected, proposed alternative would establish a Special Registration 
framework pursuant to 21 U.S.C. 802(54)(E) and 21 U.S.C. 831(h), and 
authorize three types of Special Registrations: the (1) Telemedicine 
Prescribing Registration allowing qualified clinician practitioners to 
prescribe Schedule III-V controlled substances via telemedicine; the 
(2) Advanced Telemedicine Prescribing Registration, allowing qualified 
specialized clinician practitioners (e.g., psychiatrists, hospice care 
physicians) and board-certified mid-level practitioners to prescribe 
Schedule II-V controlled substances via telemedicine, and (3) the 
Telemedicine Platform Registration for covered online telemedicine 
platforms in their capacity as platform practitioners.
    Baseline. For our analysis of the economic impact of the selected 
alternative, the baseline for the selected alternative is the period 
before the temporary COVID-19 PHE exceptions to the Ryan Haight Act. 
During the baseline period, under 21 U.S.C. 829(e), the Ryan Haight Act 
has generally required an in-person medical evaluation prior to the 
prescription of controlled substances.
    Proposed Requirements. The Ryan Haight Act does, however, provide 
an exception to this in-person medical evaluation requirement, where 
the practitioner is ``engaged in the practice of telemedicine.'' The 
Ryan Haight Act generally provides seven (7) distinct categories of the 
practice of telemedicine in which a prescribing practitioner might be 
unable to 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. The proposed requirements would allow a 
practitioner to obtain a Special Registration for Telemedicine, which 
is one of the seven categories of the practice of telemedicine as 
defined under the Ryan Haight Act. To engage in the practice of 
telemedicine under the proposed Special Registration framework, the 
practitioner must possess each of the following:
     An existing conventional DEA registration under 21 U.S.C. 
823(g);
     One of the three types of Special Registration for 
Telemedicine authorizing the prescribing of controlled substances via 
telemedicine; and
     A State Telemedicine Registration allowing the prescribing 
of controlled substances via telemedicine for each state in which a 
patient is located.

[[Page 6566]]

[GRAPHIC] [TIFF OMITTED] TP17JA25.089

As Graphic 1 shows, these types of DEA registrations are interconnected 
for the purposes of prescribing controlled substances under the Special 
Registration framework. To issue a special registration prescription to 
a patient located in a particular state, the practitioner must first 
obtain a State Telemedicine Registration for that state. However, a 
State Telemedicine Registration can only be obtained if the 
practitioner already holds or is simultaneously applying for a Special 
Registration for Telemedicine. In turn, the Special Registration for 
Telemedicine requires that the practitioner have an existing 
conventional DEA registration under 21 U.S.C. 823(g). The proposed rule 
has certain requirements for:

    1. The application process: such as reporting professional 
affiliations with employers (21 CFR 1301.13(k)(2)(i)-(ii)), medical 
specialty (as mentioned above) (21 CFR 1301.13(k)(2)(iv)), that the 
practitioner will maintain anti-diversion policies (21 CFR 
1301.13(k)(2)(iii)); and the facts and circumstances that form the 
basis for a legitimate need for a Special Registration for 
Telemedicine (21 CFR 1301.13(k)(2)(v)).
    2. The prescription process: such as PDMP checks for the patient 
state, special registrant state, and any states with reciprocity 
agreement with either state (21 CFR 1306.43(a), a comprehensive 
nationwide PDMP check for all 50 states and any U.S. districts and 
territories that maintain a PDMP, if possible, starting three years 
from the effective date of the final rule (21 CFR 1306.43(b)), all 
prescriptions issued through EPCS (21 CFR 1306.42), telemedicine 
encounters being audio-visual with limited exception (21 CFR 
1306.44), the inclusion of additional elements on special 
registration prescriptions (21 CFR 1306.47) and, for Schedule II 
controlled substances, prescriptions issued for care under an 
appropriate specialty and other safeguards (21 CFR 1306.45).
    3. Recordkeeping and reporting requirements: such as patient 
verification using photographic records (21 CFR 1304.04(i)), Special 
Registration telemedicine encounter records (21 CFR 1304.04(j)), 
credential verifications of clinician special registrants (21 CFR 
1304.04(k)), centralized recordkeeping at the special registered 
location (21 CFR 1304.04(l)), pharmacy reporting of telemedicine 
prescription data to DEA (21 CFR 1304.60) and special registrant 
reporting of the number of new telemedicine patients and 
prescription aggregated data to DEA (21 CFR 1304.61).

    The costs, cost savings, benefits, and transfers associated with 
the proposed rule were evaluated from the perspective of the following 
impacted parties: patients, practitioners (including mid-level 
practitioners), pharmacies, healthcare systems, states, and society at 
large. The high and low ranges of economic impact are based on two 
factors: the rate of telemedicine visits resulting from this proposed 
rule and the level of participation by registrants under the proposed 
rule.

II. Patient Costs, Cost Savings, and Benefits

    The proposed rule would benefit patients by reducing transportation 
costs, travel time costs, and expanding access to medical care. The 
cost savings associated with the proposed rule predominantly stem from 
reductions in two costs: (1) the cost of time, and (2) the cost of 
transportation.

A. Patient's Cost of Time per Practitioner Visit

    To derive patients' cost of time, DEA needed to assess two factors: 
the average length of time to travel and wait for a practitioner's 
appointment, and the average opportunity cost (i.e., forgone wages) to 
travel and wait for a practitioner's appointment. Simply put, (average 
length of the time) x (opportunity cost) = patient's cost of time. To 
determine an appropriate average length of time, DEA consulted relevant 
medical articles. While the practice of telemedicine proposed in this 
rule is a subset of telehealth that focuses on clinical services by 
practitioners, broader telehealth research can inform our understanding 
of telemedicine and provide a greater array of research to use in our 
analysis. It is also common for research to indicate it relates to 
``telehealth,'' even when it may be more appropriate to call it a 
``telemedicine'' study.\111\
---------------------------------------------------------------------------

    \111\ Accordingly, in discussing such studies, DEA will use the 
word the word ``telehealth'' instead of telemedicine.
---------------------------------------------------------------------------

    To determine the average length of time to be used in this 
analysis, DEA consulted various studies. A 2023 study focused on cancer 
(non-elderly) telehealth patients treated between April 1, 2020, and 
June 30, 2021. This study found that telehealth patients saved about 
2.9 hours of round-trip driving time and 1.2 hours of in-clinic time 
per visit, including time spent with a practitioner.\112\ However, as 
this study focused on non-elderly cancer patients, it did not 
adequately represent the broader scope of telehealth patients 
considered in this analysis. In contrast, a 2019 study indicated that 
the average length of time (combining travel and waiting time) was 45 
minutes (0.75 hours) per visit.\113\ Given that 68.2 percent of all 
current telehealth claims are related to mental health, not non-elderly 
cancer patients, DEA believes that the 45-minute average is more

[[Page 6567]]

relevant for this analysis.\114\ DEA, however, acknowledges that there 
may be significant variability in the average lengths of time across 
different patient populations.
---------------------------------------------------------------------------

    \112\ Patel KB, Turner K, Alishahi Tabriz A, et al. Estimated 
Indirect Cost Savings of Using Telehealth Among Nonelderly Patients 
with Cancer. JAMA Netw Open. 2023;6(1):e2250211.
    \113\ Rhyan C. Travel and Wait Times are Longest for Health Care 
Services and Result in an Annual Opportunity Cost of $89 Billion. 
Altarum. (Feb. 22, 2019), https://altarum.org/travel-and-wait 
(accessed 9/5/2023).
    \114\ Fair Health, ``Monthly Telehealth Regional Tracker.'' 
https://www.fairhealth.org/fh-trackers/telehealth. (accessed 8/4/
2023 selecting Jan 2020, which had Jan 2019 data, and May 2023 using 
National Statistics data dropdown menu).
---------------------------------------------------------------------------

    To determine an appropriate average opportunity cost (i.e., forgone 
wages) to travel and wait for a practitioner's appointment, DEA 
consulted relevant data from the U.S. Bureau of Labor Statistics (BLS). 
DEA used median hourly wage data for all occupations ($23.11) as a 
proxy for the hourly average opportunity cost of travel and wait time 
for all patients, as can be seen in Table 1 below.\115\ Additionally, 
BLS reports that average wages and salaries for civilians are 68.8 
percent of total compensation. The 68.8 percent of total compensation 
equates to 45.3 percent (100 percent/68.8 percent--1) load on wages and 
salaries.\116\ The load of 45.3 percent, or $10.47 (0.453 x $23.11), is 
added to the hourly rate to estimate the loaded hourly rates. As can be 
seen in Table 1, the loaded hourly wage for patients is $33.58 ($23.11 
+ $10.47). Therefore, the $33.58 loaded hourly wage represents the 
hourly average opportunity cost to travel and wait for a practitioner's 
appointment.
---------------------------------------------------------------------------

    \115\ Bureau of Labor Statistics, Occupational Employment and 
Wages, May 2023 National Occupational Employment and Wage Estimates, 
Occupation code: 00-0000 All Occupations, https://www.bls.gov/oes/2023/may/oes_nat.htm.
    \116\ Bureau of Labor Statistics, Employer Costs for Employee 
Compensation--June 2024, https://www.bls.gov/news.release/archives/ecec_09102024.pdf. (accessed 11/13/2024).

                                      Table 1--Patients Loaded Hourly Wage
----------------------------------------------------------------------------------------------------------------
                                                                 Hourly wage        Load for      Loaded hourly
                          Occupation                                 ($)         benefits  ($)      wage  ($)
----------------------------------------------------------------------------------------------------------------
All Occupations..............................................           23.11            10.47            33.58
----------------------------------------------------------------------------------------------------------------

    Therefore, the patient's cost of time to travel and wait for a 
practitioner's visit--and thus the time cost savings achieved by 
telemedicine patients who could forego such a trip--equals $25.19 (0.75 
x $33.58), as can be seen in Table 2 below.

                                          Table 2--Patient Cost of Time
                                        [per Practitioner's Appointment]
----------------------------------------------------------------------------------------------------------------
                                                                    Hourly                           Cost per
                         Cost savings                            opportunity    Travel and wait    appointment
                                                                  cost  ($)      time  (hours)         ($)
----------------------------------------------------------------------------------------------------------------
Time cost savings............................................           33.58             0.75            25.19
----------------------------------------------------------------------------------------------------------------

B. Patient's Cost of Travel per Practitioner Visit

    To determine the cost of travel to and from a practitioner's 
appointment, DEA used data from the Southwest Rural Health Research 
Center in the Texas A&M School of Public Health, and mileage 
reimbursement rates from the U.S. Internal Revenue Service (IRS). 
According to a 2017 survey by the Southwest Rural Health Research 
Center, the average national round-trip travel distance for a doctor's 
visit was 9.9 miles, or 19.8 miles round-trip.\117\ The IRS travel 
reimbursement rate for businesses is 67 cents per mile.\118\ Therefore, 
the patient's cost of travel to and from a practitioner's appointment--
and thus the travel cost savings achieved by telemedicine patients who 
could forego such a trip--equals $13.27 (19.8 miles x $0.67 per mile), 
as can be seen in Table 3 below.
---------------------------------------------------------------------------

    \117\ Akinlotan, M., Khodakarami, N., Primm, K., Bolin, J., and 
Ferdinand, A.O. (Yen W. Rhyan C. Rural-Urban Variations in Travel 
Burdens for Care: Findings from the 2017 National Household Travel 
July 2021. https://srhrc.tamu.edu/publications/travel-burdens-07.2021.pdf. https://ofm.wa.gov/sites/default/files/public/legacy/researchbriefs/2013/brief070.pdf (accessed 9/24/2024).
    \118\ Internal Revenue Service. Standard Mileage Rates, Notice 
2024-08, https://www.irs.gov/pub/irs-drop/n-24-08.pdf. (accessed 10/
18/2024).

                                  Table 3--Patient Travel Cost Savings per Trip
----------------------------------------------------------------------------------------------------------------
                                                               Travel cost per  Travel distance  Per appointment
                         Cost savings                             mile  ($)          (miles)        cost  ($)
----------------------------------------------------------------------------------------------------------------
Travel cost savings..........................................            0.67             19.8            13.27
----------------------------------------------------------------------------------------------------------------


[[Page 6568]]

C. Total Number of Telemedicine Visits

    The proposed rule's patient cost savings result from eliminating 
the need for an initial in-person medical evaluation or visit. 
Subsequent telemedicine visits are allowed after that initial in-person 
medical evaluation or visit, even without the COVID-19 PHE telemedicine 
flexibilities. So, to calculate the total patient cost savings under 
the proposed rule, DEA needed to estimate the total number of first-
time telemedicine visits resulting in prescriptions for controlled 
substances.\119\ Given the absence of direct information on this point, 
however, it was necessary for DEA to perform a multi-step analysis or 
derivation using different available data sources at each step to 
derive an estimate. First, DEA established the total annual 
practitioner visits using available data. Second, the total was further 
refined to those practitioner visits conducted via telemedicine. Third, 
the total was reduced to those that constituted first-time telemedicine 
visits. Fourth, DEA determined the proportion of the first-time 
telemedicine visits that would result in prescriptions. Fifth, it 
refined the total number of first-time telemedicine visits resulting in 
prescriptions of controlled substances. And lastly, DEA considered the 
impact of proposed requirements and determined the total number of 
first-time telemedicine visits resulting in prescriptions of controlled 
substances under the proposed rule. DEA performed this multi-step 
analysis to derive the low, moderate (primary), and high estimates of 
the number of first-time telemedicine visits resulting in prescriptions 
for controlled substances, which resulted in low, moderate (primary), 
and high values for the total patient cost savings.
---------------------------------------------------------------------------

    \119\ Total Patient Cost Savings = (number of first-time 
telemedicine visits resulting in prescriptions for controlled 
substances) * (patient cost savings).
---------------------------------------------------------------------------

i. Total Number of Telemedicine Visits Under the Current Telemedicine 
Rate
    Step 1: Total Annual Practitioner Visits. As described above, DEA 
initially established the total annual practitioner visits using 
available data. According to the Centers' for Disease Control and 
Prevention (CDC) 2019 National Ambulatory Medical Care (NAMC) sample 
survey, it was estimated that there were a total of 1,036,484,000 
practitioner visits that year, although not all of these visits 
resulted in prescriptions, as can be seen in Table 4.\120\ An analysis 
of this survey revealed that a total of 3,476,239,000 prescriptions 
were issued during medical visits that year, as can be seen in Table 
4.\121\ This means that for every one practitioner visit, there were 
approximately 3.35 prescriptions, calculated as a coefficient of 
roughly 0.2982, which can be seen in Table 5.
---------------------------------------------------------------------------

    \120\ U.S. Department of Health and Human Services, Centers for 
Disease Control and Prevention, National Center for Health 
Statistics. (2019). National Ambulatory Medical Care Survey: 2019 
National Summary Tables. Retrieved from https://www.cdc.gov/nchs/data/ahcd/namcs_summary/2019-namcs-web-tables-508.pdf.
    \121\ Id.

      Table 4--Estimate of Number of Prescriptions Using Visit Data
------------------------------------------------------------------------
                                          Number of     Total number of
       Number of prescriptions             visits        prescriptions
                                         (thousands)      (thousands)
------------------------------------------------------------------------
0....................................         291,394
1....................................         192,488            192,488
2....................................         129,561            259,122
3....................................          84,898            254,694
4....................................          60,766            243,064
5....................................          52,613            263,065
6....................................          34,041            204,246
And 7................................          28,900            202,300
8....................................          29,043            232,344
9....................................          23,393            210,537
10...................................          15,320            153,200
11...................................          17,034            187,374
12...................................          14,744            176,928
13...................................          13,419            174,447
14...................................          10,635            148,890
15+..................................          38,236          * 573,540
    Total............................    ** 1,036,485          3,476,239
------------------------------------------------------------------------
* Used 15 as an approximation for 15+.
** The published total shows 1,036,484, so there is a rounding error of
  1.


         Table 5--Estimate of Visit per Prescription Coefficient
------------------------------------------------------------------------
                     NAMC visits                         1,036,484,000
------------------------------------------------------------------------
NAMC prescriptions...................................      3,476,239,000
Prescriptions per visits ratio.......................               3.35
Visit per prescription coefficient...................             0.2982
------------------------------------------------------------------------

    To estimate the total number of practitioner's visits, DEA did not 
use the NAMC survey because the survey results have been volatile year-
to-year, and it only includes ``nonfederal office-based patient care 
physicians, excluding anesthesiologists, radiologists, and 
pathologists.'' \122\ Instead, DEA used the derived coefficient in 
conjunction with IQVIA's more comprehensive 2019 prescription data to 
derive a more representative figure.\123\ In 2019, IQVIA reported 
4,386,834,000 prescriptions.\124\ By multiplying this number by the 
coefficient 0.2982, DEA estimated that there were approximately 
1,308,153,900 practitioner visits, as can be seen in Table 6.
---------------------------------------------------------------------------

    \122\ From the survey: ``Due to uncertainty regarding the true 
number of out-of-scope physicians in the 2018 NAMCS, the weighted 
frequency estimates for 2018 should be treated with caution. 
However, proportional estimates were not found to be significantly 
different between the 2018 NAMCS and 2019 NAMCS.''
    \123\ The IQVIA Institute. The Use of Medicines in the U.S. 
2023. May 02, 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/the-use-of-medicines-in-the-us-2023 (accessed 4/23/2024) reports 4,437 million for 2019 
unadjusted, but 6,218 million adjusted. A DEA IQVIA query of chain 
store prescriptions for 2019 was 4,386,834,000 but would be higher 
if food stores and independent were included. Ultimately, the 
3,476,239,000 number from the survey appears low. However, even the 
number DEA used could be considered low, but DEA has chosen to be 
conservative.
    \124\ Id.

[[Page 6569]]



           Table 6--Estimate of Number of Practitioner Visits
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Coefficient..........................................             0.2982
IQVIA prescriptions..................................      4,386,834,000
Visits--IQVIA prescriptions..........................      1,308,153,900
------------------------------------------------------------------------

    Step 2: Rate of Telemedicine. DEA then further refined the total 
number of practitioner visits to those conducted through telemedicine. 
According to the Fair Health Monthly Telehealth Regional Tracker, as of 
July 2024, 4.7 percent of medical claims were conducted through 
telehealth.\125\ As can be seen in Table 7, DEA then used this 
percentage to refine the total 1,308,153,900 practitioner visits to 
those likely to be conducted through telemedicine once a final rule is 
promulgated. Applying 4.7 percent, or the current telemedicine rate, to 
the 1,308,153,900 total practitioner's visits gives a total of 
68,024,003 practitioner visits conducted via telemedicine, as can be 
seen in Table 7.
---------------------------------------------------------------------------

    \125\ Fair Health, ``Monthly Telehealth Regional Tracker.'' 
https://www.fairhealth.org/fh-trackers/telehealth. (accessed 10/19/
2024 selecting July 2024 using National Statistics data dropdown 
menu).

                 Table 7--Number of Telemedicine Visits
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Total practitioner visits............................      1,308,153,900
Telemedicine rate....................................              0.047
Telemedicine visits..................................         68,024,003
------------------------------------------------------------------------

    Step 3: First-Time Visits. DEA needed to further refine the total 
number of telemedicine practitioner visits to those that constituted 
first-time telemedicine visits. DEA's focus on first-time telemedicine 
practitioner visits, rather than all telemedicine visits, was to 
prevent an overestimation of the total patient cost savings. Under the 
status quo, after one bona fide in-person medical evaluation, patients 
are typically permitted to be seen via telehealth thereafter when 
receiving prescriptions for controlled substances. A potential 
overestimate of total patient cost savings arises from the fact that 
patient cost savings under the proposed rule primarily hinge on the 
bypassing of a first-time, in-person medical evaluation, but not 
subsequent telemedicine visits.
    A 2022 study analyzing trends between 2017-2020 in interstate 
telehealth use by Medicare beneficiaries, a subset of the population 
impacted by the proposed rule, shows that the vast majority of 
practitioner visits are for returning patients, and approximately 10 
percent of those practitioner visits are new visits.\126\ This is in 
line with the CDC's 2019 NAMC nonfederal survey where 16.8 percent of 
office visits were for new patients. The CDC's 2019 NAMC survey, 
however, was not limited to telehealth visits, so DEA decided that the 
10 percent estimate from the 2022 interstate telehealth study was more 
applicable to this analysis.\127\ Taking 10 percent of 68,024,003 
practitioner visits conducted via telemedicine would provide a total of 
approximately 6,802,400 first-time, telemedicine practitioner visits, 
as can be seen in Table 8.
---------------------------------------------------------------------------

    \126\ Andino, J. J., Zhu, Z., Surapaneni, M., Dunn, R. L., & 
Ellimoottil, C. (2022). Interstate Telehealth Use by Medicare 
Beneficiaries Before and After COVID-19 Licensure Waivers, 2017-20. 
Health Affairs, 41(6). Appendix Exhibit 1 show that in person level 
3 and level 4 new visits are 6.8% (3.5% + 3.3%) and out-of-state new 
visits are 10.7% (5.6% + 5.1%).
    \127\ U.S. Department of Health and Human Services, Centers for 
Disease Control and Prevention, National Center for Health 
Statistics. (2019). National Ambulatory Medical Care Survey: 2019 
National Summary Tables. Retrieved from https://www.cdc.gov/nchs/data/ahcd/namcs_summary/2019-namcs-web-tables-508.pdf.

            Table 8--Number of First-Time Telemedicine Visits
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Telemedicine visits..................................         68,024,003
First-time telemedicine visit rate...................                0.1
First-time telemedicine visits.......................          6,802,400
------------------------------------------------------------------------

    Step 4: Visits Resulting in Prescriptions. DEA needed to determine 
the fraction of first-time telemedicine visits that would result in 
prescriptions. Looking again at CDC's 2019 NAMC survey (Table 4 above), 
DEA determined, as reflected in Table 4, that 291,394,000 visits did 
not include any prescribing, which means 745,090,000 of the 
1,036,484,000 visits, or approximately 72 percent of the visits, did in 
fact result in the issuance of prescriptions. Because only 72 percent 
of visits resulted in a prescription, DEA applied the 72 percent to the 
calculated 6,802,400 first-time, telemedicine visits resulting in 
approximately a total of 4,889,996 first-time telemedicine visits 
resulting in the issuance of prescriptions, as can be seen in Table 9.

[[Page 6570]]



   Table 9--Estimate of Number of First-Time Telemedicine Visits With
                              Prescriptions
------------------------------------------------------------------------
 
------------------------------------------------------------------------
First-time telemedicine visits.......  .................       6,802,400
NAMC survey visits--total............      1,036,484,000  ..............
NAMC survey visits--0 prescriptions..        291,394,000  ..............
NAMC survey rate--0 prescriptions....               0.28  ..............
NAMC survey rate--with prescriptions.               0.72          * 0.72
First-time telemedicine visits with    .................       4,889,996
 prescriptions.......................
------------------------------------------------------------------------
* Rounded.

    Step 5: Prescriptions for Controlled Substances. DEA then refined 
the total number of first-time telemedicine visits resulting in 
prescriptions for controlled substances. According to the Federal Trade 
Commission (FTC), Surescripts has 95% market share in e-prescribing 
services as of 2023.\128\ DEA was able to use 2021 data from the 
Surescripts National Progress Report to determine that approximately 16 
percent of all prescriptions (paper and electronic) are for controlled 
substances.\129\ Applying this 16 percent to the total number of 
4,889,996 telemedicine visits resulting in the issuance of 
prescriptions, provides a value of approximately 782,399 first-time 
telemedicine visits resulting in prescriptions for controlled 
substances, as can be seen in Table 10.
---------------------------------------------------------------------------

    \128\ FTC Reaches Proposed Settlement with Surescripts in 
Illegal Monopolization Case Federal Trade Commission. (July 27, 
2023), https://www.ftc.gov/news-events/news/press-releases/2023/07/ftc-reaches-proposed-settlement-surescripts-illegal-monopolization-case (accessed 9/24/2024).
    \129\ According to the Surescripts National Progress Report, 
there were 256.9 million prescriptions of controlled substances 
prescribed through EPCS, accounting for 73 percent of the total 
number of prescriptions of controlled substances. Using these 
figures, DEA derived the total number of prescriptions of controlled 
substances to be 351.9 million ((256.9 million) * (100)/(73) = 351.9 
million). There were 2.12 billion prescriptions of controlled 
substances and non-controlled substances prescribed electronically, 
accounting for 94 percent of the total number of all prescriptions 
paper or electronic for controlled substances or non-controlled 
substances. DEA derived the total number of all prescriptions paper 
or electronic for controlled substances or non-controlled substances 
to be 2.26 billion ((2.12 billion) * (100)/(94) = 2.26 billion). 
Using the total of all controlled substances prescriptions (351.9 
million) and the total of all prescriptions (2.26 billion), DEA 
determined that 16% of all prescriptions are for controlled 
substances ((256.9 million) * (100)/2.26 billion = 16 percent).

 Table 10--Current Estimate of Number of First-Time Telemedicine Visits
           Resulting in Prescriptions of Controlled Substances
------------------------------------------------------------------------
 
------------------------------------------------------------------------
First-time telemedicine visits with prescriptions.......    4,889,995.73
Controlled substance (CS) rate..........................            0.16
First-time telemedicine visits with CS prescriptions....         782,399
------------------------------------------------------------------------

    Step 6: Effect of the Proposed Rule. Lastly, DEA determined the 
total number of first-time telemedicine visits resulting in 
prescriptions of controlled substances under the proposed rule. Under 
the proposed rule, patients would not have an in-person follow-up visit 
after the first-time telemedicine visit; they would never have to see 
the prescribing practitioner in person. Based on a study by Epic 
Research of primary care visits between March 1, 2020, and October 15, 
2022, 61 percent of telehealth visits did not require an in-person 
follow-up.\130\ A similar study by Epic Research on specialty visits 
provided that 85 percent of mental health and psychiatry telehealth 
visits did not have an in-person follow-up visit.\131\ Because this 
proposed rule is not limited to mental health, DEA applied the broader 
and lower 61 percent to the 782,399 first-time telemedicine visits 
resulting in prescriptions of controlled substances. The multi-step 
analysis ultimately derived a current estimate of 477,264 first-time 
telemedicine visits resulting in prescriptions of controlled substances 
under the proposed rule, as can be seen in Table 11.
---------------------------------------------------------------------------

    \130\ Gerhart J, Piff A, Bartelt K, Barkley E. Most Primary Care 
Telehealth Visits Unlikely to Need In-Person Follow-Up. Epic 
Research. https://www.epicresearch.org/articles/most-primary-care-telehealth-visits-unlikely-to-need-in-person-follow-up (accessed 10/
20/2024).
    \131\ Gerhart J, Piff A, Bartelt K, Barkley E. Telehealth Visits 
Unlikely to Require In-Person Follow-Up Within 90 Days. Epic 
Research. https://epicresearch.org/articles/telehealth-visits-unlikely-to-require-in-person-follow-up-within-90-days. (accessed 
10/20/2024).

 Table 11--Current Estimate of Number of First-Time Telemedicine Visits Resulting in Prescriptions of Controlled
                                       Substances Under the Proposed Rule
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
NAMC visits....................   1,036,484,000  ..............  ..............  ...............  ..............
NAMC prescriptions.............   3,476,239,000  ..............  ..............  ...............  ..............
Prescriptions per visits ratio.            3.35  ..............  ..............  ...............  ..............
Visit per prescription                   0.2982          0.2982  ..............  ...............  ..............
 coefficient...................
IQVIA prescriptions............  ..............   4,386,834,000  ..............  ...............  ..............
Visits--IQVIA prescriptions....  ..............   1,308,153,900   1,308,153,900  ...............  ..............
Telemedicine rate..............  ..............  ..............           0.047  ...............  ..............
Telemedicine visits............  ..............  ..............      68,024,003      68,024,003   ..............
First time telemedicine visit    ..............  ..............  ..............             0.1   ..............
 rate..........................
First-time telemedicine visits.  ..............  ..............  ..............       6,802,400   ..............
NAMC survey visits--total......   1,036,484,000  ..............  ..............  ...............  ..............
NAMC survey visits--0               291,394,000  ..............  ..............  ...............  ..............
 prescriptions.................
NAMC survey rate--0                        0.28  ..............  ..............  ...............  ..............
 prescriptions.................
NAMC survey rate--with                     0.72  ..............  ..............            0.72   ..............
 prescriptions.................
First-time telemedicine visits   ..............  ..............  ..............       4,889,996        4,889,996
 with prescriptions............
Controlled substance (CS) rate.  ..............  ..............  ..............  ...............            0.16
First-time telemedicine visits   ..............  ..............  ..............  ...............         782,399
 with CS prescriptions.........
First-time telemedicine visits   ..............  ..............  ..............  ...............            0.61
 that do not have an in-person
 follow up visit...............

[[Page 6571]]

 
First-time telemedicine visits   ..............  ..............  ..............  ...............         477,264
 under the proposed rule with
 CS prescriptions..............
----------------------------------------------------------------------------------------------------------------

ii. Forecasted Total Number of Telemedicine Visits
    To project the future level of telemedicine visits, a forecast is 
required, utilizing the usage rate of telemedicine.\132\ A forecast has 
two critical elements:
---------------------------------------------------------------------------

    \132\ The usage rate of telemedicine is the percent of medical 
visits conducted via telemedicine.
---------------------------------------------------------------------------

    1. Baseline (or starting) value, and the
    2. Growth rate from that baseline value.
    A typical forecast relies on the existing value and the historic 
data to extrapolate an expected growth rate. However, this process 
becomes more complex with volatile historical data, as fluctuations 
make it challenging to determine a stable baseline and reliable growth 
trend.\133\ In the case of telemedicine, the past five years have seen 
significant volatility in usage rates, resulting in baseline level and 
growth rates that have been significantly distorted, with the rate both 
increasing and decreasing depending on the time interval, as can be 
seen in Table 12. Specifically, the rate of telemedicine usage surged 
from 0.2 percent in 2019 to 13 percent in the April 2020 peak according 
to Fair Health's analysis of medical claims and to 31.2 percent in the 
second quarter of 2020 based on an analysis of doctor visits by Epic 
Research. \134\ However, this trend reversed in subsequent years, with 
rates gradually declining. By the third quarter of 2023, the 
telemedicine usage rate had dropped to 5.8%, and as of July 2024, it 
stood at 4.7 percent, based on data from Epic Research.\135\
---------------------------------------------------------------------------

    \133\ For instance, for those who want to understand the 
potential of an economy, recessions may distort Gross Domestic 
Product (GDP) data. To counter that distortion interested parties 
may think in terms of the GDP at full employment and think how that 
full employment GDP grows every year. For some background see 
Universities-National Bureau Committee for Economic Research. The 
Measurement and Behavior of Unemployment. 1957. https://www.nber.org/system/files/chapters/c2638/c2638.pdf (accessed 10/20/
2024).
    \134\ Monthly Telehealth Regional Tracker, Fair Health, https://www.fairhealth.org/fh-trackers/telehealth. (accessed 8/4/2023 
selecting April 2020, which had April 2019 data, using National 
Statistics data dropdown menu); Bartelt K, Piff A, Allen S, Barkley 
E. Telehealth Utilization Higher Than Pre-Pandemic Levels, but Down 
from Pandemic Highs. Epic Research. https://www.epicresearch.org/articles/telehealth-utilization-higher-than-pre-pandemic-levels-but-down-from-pandemic-highs (accessed 10/19/2024), S&P Global. 
Telehealth finds mental health, provider niche as usage drops from 
pandemic peak. September 9, 2021. https://www.spglobal.com/marketintelligence/en/news-insights/latest-news-headlines/telehealth-finds-mental-health-provider-niche-as-usage-drops-from-pandemic-peak-66229670 (accessed 10/1/2024); The difference in the 
peak levels of demand could be due to Fair Health looking at claims 
that include filling prescription drugs and other non-visit related 
claims. However, Fair Health does look at a much larger volume of 
claims, possibly over 3 billion each year (https://www.fairhealth.org/data), than the Epic Research study, which only 
studied 475 million claims throughout the entire study period.
    \135\ Monthly Telehealth Regional Tracker, Fair Health, https://www.fairhealth.org/fh-trackers/telehealth. (accessed 10/19/2024 
selecting July 2024 using National Statistics data dropdown menu).

                                                         Table 12--Historical Telemedicine Rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                           Epic research
                   Year                                 Month               Fair health     YOY change        Quarter         (doctor       YOY change
                                                                           (claims)  (%)        (%)                        visits)  (%)         (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
2019......................................  April.......................            0.15  ..............              2Q             0.2  ..............
2020......................................  April.......................            13.0          8566.7              2Q            31.2         15500.0
2021......................................  ............................  ..............  ..............              2Q             9.1           -70.8
2022......................................  ............................  ..............  ..............              2Q             7.1           -22.0
2023......................................  May.........................             5.4  ..............              2Q             6.0           -15.5
2024......................................  May.........................             4.8           -11.1  ..............  ..............  ..............
2024......................................  July........................             4.7  ..............  ..............  ..............  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Uncertainty and Factors that May Affect Future Telemedicine Usage. 
The future of telemedicine is difficult to predict. Patients may start 
to embrace telemedicine again, or they may continue to return to in-
person visits as pandemic habits recede, especially given the lack of 
in-person exams and vital sign measurements in telehealth.\136\ This 
uncertainty is reflected in corporate behavior. In March 2023, Walmart 
announced plans to further expand its telehealth services by opening 28 
additional health centers.\137\ However, less than a year later, in May 
2024, the company reversed course, announcing the closure of all 51 of 
their health centers and its telehealth service as it no longer 
believed it a sustainable business model.
---------------------------------------------------------------------------

    \136\ SteelFisher GK, McMurtry CL, Caporello H, Lubell KM, 
Koonin LM, Neri AJ, Ben-Porath EN, Mehrotra A, McGowan E, Espino LC, 
Barnett ML. Video Telemedicine Experiences In COVID-19 Were 
Positive, But Physicians and Patients Prefer In-Person Care for The 
Future. Health Aff (Millwood). April 2023.
    \137\ The Associated Press. Walmart says it will close its 51 
health centers and virtual care service. NPR. May 1, 2024. https://
www.npr.org/2024/05/01/1248397756/walmart-close-health-centers-
virtual-care#:~:text=the%20asset%27s%20value.-
,Sponsor%20Message,vision%20centers%20in%20the%20U.S. (accessed 10/
31/2024).
---------------------------------------------------------------------------

    Even if the rule proposed in this NPRM were finalized, it remains 
unclear how state-level regulations will evolve and impact the 
telemedicine market. While 43 states and the District of Columbia (DC) 
may require commercial insurers to cover telehealth services (coverage 
parity), only a handful of states mandate equal reimbursement rates for 
telehealth and in-person care (payment parity).\138\ Further, some 
states have rolled back telemedicine flexibilities introduced during 
the pandemic and reverted to pre-pandemic restrictions. As of December 
2023, 30 states have banned or heavily restricted telehealth 
appointments with out-of-state doctors.\139\
---------------------------------------------------------------------------

    \138\ Ellimoottil C. Understanding the Case for Telehealth 
Payment Parity. Health Affairs. May 10, 2021. https://www.healthaffairs.org/content/forefront/understanding-case-telehealth-payment-parity (accessed 10/31/2024).
    \139\ Trotter C. In 30 states, you cannot use telehealth with 
out-of-state doctors. Pacific Legal Foundation. December 13, 2023. 
https://pacificlegal.org/30-states-telehealth-rules/ (accessed 10/
24/2024).
---------------------------------------------------------------------------

    Technology could also play a critical role in shaping the 
telemedicine market.

[[Page 6572]]

For example, technological advances could reduce the cost of remote 
patient monitoring devices, further driving the demand of 
telemedicine.\140\ On the other hand, some communities may still not be 
able to utilize telemedicine in their homes, because they continue to 
lack the broadband internet to support the technology either because 
such broadband service is unavailable or unaffordable.\141\ Ultimately, 
the telemedicine market has been shaped by a shifting landscape of 
factors, making it difficult to pinpoint any one baseline value or rate 
of growth with any certainty.
---------------------------------------------------------------------------

    \140\ Serrano LP, Maita KC, Avila FR, Torres-Guzman RA, Garcia 
JP, Eldaly AS, Haider CR, Felton CL, Paulson MR, Maniaci MJ, Forte 
AJ. Benefits and Challenges of Remote Patient Monitoring as 
Perceived by Health Care Practitioners: A Systematic Review. Perm J. 
Dec 2023.
    \141\ U.S. Government Accountability Office. Closing the Digital 
Divide for the Millions of Americans without Broadband. WatchBlog. 
February 01, 2023. https://www.gao.gov/blog/closing-digital-divide-
millions-americans-without-
broadband#:~:text=Closing%20the%20digital%20divide%20is,and%20Informa
tion%20Administration%20(NTIA)(accessed 10/31/2024).
---------------------------------------------------------------------------

    Low, Moderate (Primary), and High Estimates. Given these 
uncertainties, DEA analyzed a range of possible baseline values and 
growth rates for telemedicine usage (i.e., rates of telemedicine) to 
demonstrate a range of possible outcomes. This approach allows for the 
derivation of a low, moderate, and high estimate of the total number of 
telemedicine visits over the next 10 years.
     For the low estimate, DEA selected a baseline telemedicine 
usage rate of 0.2 percent, reflecting the lower levels of use observed 
in 2019, prior to the COVID-19 pandemic. A growth rate of 2 percent was 
chosen, corresponding to the projected growth rate of primary care 
between 2022 and 2026.\142\
---------------------------------------------------------------------------

    \142\ Jain S. Projected Growth in Demand for Healthcare Services 
is Tepid. Trilliant Health: The Compass. 11/6/2022, https://www.trillianthealth.com/market-research/studies/projected-growth-in-demand-for-healthcare-services-is-tepid (accessed 10/24/2024).
---------------------------------------------------------------------------

     For the moderate (primary) estimate, DEA used a baseline 
telemedicine usage rate of 4.7 percent, mirroring the current rate of 
telemedicine. A growth rate of 4.95% was derived by taking the average 
of two different projections: a robust growth rate of 19 percent and a 
negative rate of -9.1 percent.\143\
---------------------------------------------------------------------------

    \143\ Adjusting the recent decline in the rate of telemedicine 
of 11.1 percent by the 2.0 percent growth of overall doctor visits 
means telemedicine visits may have fallen 9.1%. The 19 percent was 
taken from Fortune Business Insight. Telemedicine Market Size, Share 
& Industry Analysis, By Type (Products and Services), By Modality 
(Store-and-forward (Asynchronous), Real-time (Synchronous), and 
Others), By Application (Teleradiology, Telepathology, 
Teledermatology, Telecardiology, Telepsychiatry, and Others), By 
End-User (Healthcare Facilities, Homecare, and Others), and Regional 
Forecast, 2024-2032 https://www.fortunebusinessinsights.com/industry-reports/telemedicine-market-101067 (Accessed 10/20/24); For 
simplicity a single growth rate was assumed. However, an alternative 
measure could project the gradual slowing of the annual decline of -
22 percent, -15.5 percent, and -11.1 percent from Table 12. Just 
using the change in decline in latest data of 4.4 percent (15.5-
11.1) would give -6.7 percent in year 1, -2.3 percent in year 2, 2.1 
percent in year 3, 6.5 percent in year 4, 10.9 percent in year 5, 
15.3 percent in year 6, and 19.7 percent in year 7. This is probably 
more in line with the expected course of telemedicine but is still 
uncertain.
---------------------------------------------------------------------------

     For the high estimate, DEA selected a baseline 
telemedicine usage rate of 13 percent, reflecting the usage observed at 
the April 2020 peak by Fair Health's more comprehensive claims data 
during the pandemic. A growth rate of 19 percent was chosen based on 
estimates from one source, Fortune Business Insights, which projected 
that growth rate per year between 2024 and 2032.\144\
---------------------------------------------------------------------------

    \144\ Fortune Business Insight. Telemedicine Market Size, Share 
& Industry Analysis, By Type (Products and Services), By Modality 
(Store-and-forward (Asynchronous), Real-time (Synchronous), and 
Others), By Application (Teleradiology, Telepathology, 
Teledermatology, Telecardiology, Telepsychiatry, and Others), By 
End-User (Healthcare Facilities, Homecare, and Others), and Regional 
Forecast, 2024-2032 https://www.fortunebusinessinsights.com/industry-reports/telemedicine-market-101067 (Accessed 10/20/24).
---------------------------------------------------------------------------

    The scenarios provided are informed projections, based on factors 
that could influence telemedicine usage and growth. While these 
projections draw on available data and insights from healthcare, they 
are ultimately speculative. The scenarios are summarized in Table 13 
below.

                                    Table 13--Summary of the Three Scenarios
----------------------------------------------------------------------------------------------------------------
                                              Telemedicine
                  Scenario                      Rate  (%)      Growth  (%)                  Demand
----------------------------------------------------------------------------------------------------------------
Low........................................            0.20               2  Telemedicine usage returns to pre-
                                                                              pandemic level with low growth,
                                                                              corresponding to demand for
                                                                              healthcare services.
Moderate (Primary).........................            4.70            4.95  Telemedicine usage remains at
                                                                              current level with moderate
                                                                              growth.
High.......................................            * 13              19  Telemedicine usage surges to the
                                                                              pandemic peak level and grows at
                                                                              high growth rate.
----------------------------------------------------------------------------------------------------------------

    As seen in Table 11, ``telemedicine rate'' of ``0.047'' (4.7 
percent) is a key factor in estimating ``first-time telemedicine visits 
under the proposed rule with [controlled substance] prescriptions'' of 
477,264. Varying the ``telemedicine rate'' to 0.2 percent and 13 
percent would result in ``first-time telemedicine visits under the 
proposed rule with [controlled substance] prescriptions'' to 20,309 
(477,264 x (0.2/4.7)) and 1,320,092 (477,264 x (13/4.7)), respectively. 
DEA estimates the number of first-time telemedicine visits under the 
proposed rule with controlled substance prescriptions would reach these 
levels in the first year of implementation of this proposed rule. Table 
14 below summarizes the first-year numbers and growth rates of first-
time telemedicine visits under the proposed rule with controlled 
substance prescriptions for the low, moderate (primary), and high 
estimates.

                                  Table 14--``Year 1'' Visits and Growth Rates
----------------------------------------------------------------------------------------------------------------
                                                                                     Moderate
                                                                        Low          (primary)         High
----------------------------------------------------------------------------------------------------------------
(Year 1) First-time telemedicine visits under the proposed rule           20,309         477,264       1,320,092
 with CS prescriptions..........................................
Annual Growth Rate..............................................           2.00%           4.95%          19.00%
----------------------------------------------------------------------------------------------------------------


[[Page 6573]]

    Applying the growth rates to the `Year 1' patient visit figures, 
DEA generated a 10-year forecast as shown in Table 15 below.

                                                           Table 15--Number of Visits Forecast
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Low                     Moderate  (primary)                    High
                                                         -----------------------------------------------------------------------------------------------
                          Year                              Growth rate                     Growth rate                     Growth rate
                                                                (%)       Patient visits        (%)       Patient visits        (%)       Patient visits
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.......................................................  ..............          20,309  ..............         477,264  ..............       1,320,092
2.......................................................               2          20,715            4.95         500,889              19       1,570,909
3.......................................................               2          21,129            4.95         525,683              19       1,869,382
4.......................................................               2          21,552            4.95         551,704              19       2,224,565
5.......................................................               2          21,983            4.95         579,013              19       2,647,232
6.......................................................               2          22,423            4.95         607,674              19       3,150,206
7.......................................................               2          22,871            4.95         637,754              19       3,748,745
8.......................................................               2          23,328            4.95         669,323              19       4,461,007
9.......................................................               2          23,795            4.95         702,454              19       5,308,598
10......................................................               2          24,271            4.95         737,225              19       6,317,232
--------------------------------------------------------------------------------------------------------------------------------------------------------

D. Total Patient Cost Savings

    Each telemedicine visit saves patients time and travel costs of 
$25.19 and $13.27, respectively, for a total savings of $38.46. 
Applying the cost savings of $38.46 to the estimated number of first-
time telemedicine visits under the proposed rule with controlled 
substance prescriptions results in a 10-year forecast of patient cost 
savings for low, moderate (primary), and high scenarios as shown in 
Table 16 below.

                                   Table 16--Patient Annual Total Cost Savings
----------------------------------------------------------------------------------------------------------------
                                                                                     Moderate
                              Year                                   Low  ($)     (primary)  ($)     High  ($)
----------------------------------------------------------------------------------------------------------------
1...............................................................         781,084      18,355,573      50,770,738
2...............................................................         796,699      19,264,191      60,417,160
3...............................................................         812,621      20,217,768      71,896,432
4...............................................................         828,890      21,218,536      85,556,770
5...............................................................         845,466      22,268,840     101,812,543
6...............................................................         862,389      23,371,142     121,156,923
7...............................................................         879,619      24,528,019     144,176,733
8...............................................................         897,195      25,742,163     171,570,329
9...............................................................         915,156      27,016,381     204,168,679
10..............................................................         933,463      28,353,674     242,960,743
Present Value *.................................................       7,657,624     205,278,372   1,096,535,599
Annualized Cost *...............................................         852,497      22,852,928     122,073,501
----------------------------------------------------------------------------------------------------------------
* Present value and annualized values are based on a two percent (2%) discount rate.

E. Patient Benefit: Increased Access to Care

    DEA believes this proposed rule may improve patient access to care. 
However, DEA maintains that telemedicine is not as effective as in-
person visits. According to a NCHS Data Brief from February 2024, only 
4.0 percent of primary care physicians, 6.3 percent of surgical 
specialty physicians, and 6.0 percent of medical special physicians 
believe telemedicine is as effective as in-person visits.\145\
---------------------------------------------------------------------------

    \145\ Myrick K, Mahar M, DeFrances CJ. Telemedicine Use Among 
Physicians by Physician Specialty: United States, 2021. NCHS Data 
Brief, no 493. February 2024. https://www.cdc.gov/nchs/data/databriefs/db493.pdf.
---------------------------------------------------------------------------

    Telemedicine has emerged as a vital solution for enhancing 
healthcare accessibility, especially in the face of healthcare 
shortages. Notably, it extends its benefits to patients in remote and 
other underserved areas, including by providing access to specialized 
care. As of July 2024, telehealth utilization is 4.7 percent of medical 
claims (Table 12), a significant leap from the 0.17 percent recorded in 
January 2019, before the COVID-19 pandemic, demonstrating its growing 
importance.\146\ Most notably, mental health claims using telehealth 
had risen from 39.6 percent to 68.2 percent during this period, 
demonstrating that the utilization of telemedicine for mental 
healthcare experienced a significant surge during the pandemic.\147\
---------------------------------------------------------------------------

    \146\ Monthly Telehealth Regional Tracker, Fair Health, https://www.fairhealth.org/fh-trackers/telehealth. (accessed 8/4/2023 
selecting Jan 2020, which had Jan 2019 data, and May 2023 using 
National Statistics data dropdown menu).
    \147\ Id.
---------------------------------------------------------------------------

    The importance of telemedicine becomes even more apparent when 
considering the acute shortage of mental health professionals. Over 75 
percent of all U.S. counties are classified as having mental health 
shortage areas, with 50 percent lacking any mental health 
professionals. Long-distance travel for treatment remains a major 
accessibility barrier for individuals in rural areas with limited 
transportation options.\148\ As of June 2023, there were 6,546 
designated ``Mental Health--Health Professional Shortage Areas'' 
covering a total population of 163,355,252

[[Page 6574]]

people.\149\ However, it is crucial to note that the healthcare 
shortage issue extends beyond mental health professionals. A September 
2022 report revealed that 97.6 million Americans live in areas with a 
primary health professional shortage, highlighting a broad need for 
enhanced access to a range of specialties.\150\
---------------------------------------------------------------------------

    \148\ Substance Abuse and Mental Health Services Administration, 
Rural Behavioral Health: Telehealth Challenges and Opportunities, at 
4 (2016), https://store.samhsa.gov/sites/default/files/sma16-4989.pdf.
    \149\ Health Resources and Services Administration, Designated 
Health Professional Shortage Area Statistics, Third Quarter of 
Fiscal Year 2023 Designated HRSA Quarterly Summary (2023).
    \150\ KFF, ``Primary Care Health Professional Shortage Areas 
(HPSAs),'' September 30, 2022, https://www.kff.org/other/state-indicator/primary-care-health-professional-shortage-areas-hpsas/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D. (accessed 8/4/2023).
---------------------------------------------------------------------------

    The utilization of telehealth is more prevalent among urban 
Americans and Americans between the ages of 31 to 50 with respect to 
non-hospital-based provider-to-patient telehealth claims, which is the 
largest category of telehealth.\151\ However, when examining discharge-
related provider-to-patient telehealth claims, rural Americans and 
those over age 50 are the most prevalent.\152\ DEA is not certain as to 
why these disparities exist, but they could suggest that limited access 
to routine and preventative care in rural areas and for older patients 
result in higher rates of hospitalizations, leading to more discharge-
related provider-to-patient telehealth claims. With greater access, 
rural Americans and older patients may increase their non-hospital-
based provider-to-patient telemedicine. With the potential for a 
broader range of telemedicine practices enabled by the proposed Special 
Registration framework, qualified practitioners and MLPs could 
effectively reach a larger patient population, ultimately resulting in 
improved healthcare outcomes and reduced costs for patients across the 
nation.
---------------------------------------------------------------------------

    \151\ Fair Health ``A Multilayered Analysis of Telehealth,'' 
July 2019.
    \152\ Id.
---------------------------------------------------------------------------

    As discussed further below, healthcare systems may, instead of 
lowering costs, be able to provide increased care at a similar cost 
based on an evaluation of health care systems.\153\ While practitioners 
may be able to reduce travel to and from the office, this time saving 
is likely much less than patients' since practitioners may still go to 
the office and may see many patients. However, this travel time savings 
may allow practitioners to become more available to patients, 
increasing access to care. While DEA is unable to quantify all the 
benefits to increased patient access to care, DEA believes it is not 
negligible.

III. Practitioner and MLP Costs, Cost Savings, and Transfers

    The proposed rule would impact qualified practitioners (limited to 
physicians, mid-level practitioners, and covered online telemedicine 
platforms) by imposing registration costs, imposing recordkeeping 
costs, creating transfer payments, allowing for travel cost savings, 
and allowing for greater demand for their services. Costs of the 
proposed rule are specific to the cost of applying for the conventional 
registration (for covered online telemedicine platforms), Special 
Registration for Telemedicine, State Telemedicine Registration, and for 
PDMP checks due to the increased risk of diversion from more 
practitioners having the authority to prescribe Schedule II-V 
controlled substances. DEA estimates that there will be no additional 
infrastructure cost for patients or providers with the Special 
Registration for Telemedicine, as DEA has concluded that most patients 
and providers will already possess or have ready access to a 
telecommunications system meeting the requirements of the proposed 
rule. An analysis of all costs is detailed below.
---------------------------------------------------------------------------

    \153\ Snoswell CL, Taylor ML, Comans TA, Smith AC, Gray LC, 
Caffery LJ. Determining if Telehealth Can Reduce Health System 
Costs: Scoping Review. J Med internet Res. Oct 2020.
---------------------------------------------------------------------------

A. Number of Conventional Registrations, Special Registrations, and 
State Telemedicine Registrations

    When it comes to analyzing the costs, cost savings, benefits, and 
transfers of practitioners, DEA has to consider that qualified 
practitioners will need to apply for two new types of registrations, 
with covered online telemedicine platforms needing to first ensure that 
they have a conventional registration with DEA pursuant to 21 U.S.C. 
823(g) in their capacity as a platform practitioner. As discussed 
above, practitioners will have to apply for a Special Registration 
(either the Telemedicine Prescribing Registration, the Advanced 
Telemedicine Prescribing Registration, or the Telemedicine Platform 
Registration), as well as State Telemedicine Registrations (either 
State Telemedicine Registration for Clinician Special Registrants or 
State Telemedicine Registration for Platform Special Registrants), an 
ancillary type of registration required for each state in which 
patients are located that will be treated by the practitioner.
    The number of conventional registrations under 21 U.S.C. 823(g) 
will be equal to the number of Telemedicine Platform Registrations, 
because one conventional registration is required to obtain a 
Telemedicine Platform Registration; currently, no online telemedicine 
platforms have a conventional registration. As a starting point to 
determine the number of conventional registrations, Special 
Registrations and State Telemedicine Registrations to be expected under 
the proposed rule, DEA first looked at current registrations held by 
practitioners. For the number of covered online telemedicine platforms, 
DEA used the number of telemedicine companies as a proxy.
    As of October 19, 2024, there were 2,153,900 DEA registrants.\154\ 
Among them, 1,122,940 were physicians who fall under this proposed rule 
(medical doctors and doctors of osteopathy), 403,748 were nurse 
practitioners (``NPs''), and 168,201 were physician assistants 
(``PAs''), as shown in Table 17 below.\155\ These numbers exceed the 
actual employment figures in these fields. Specifically, there are 
770,850 physicians, 280,140 nurse practitioners, and 145,740 physician 
assistants according to BLS.\156\ This variation can be attributed to 
the fact that some registrants maintain registrations in multiple 
states or locations.\157\ The number of employed can serve as a proxy 
for primary registrations, i.e. the 823(g) registration predominantly 
used by a practitioner, while the difference between these two sets of 
numbers (number of registrants and employment numbers) provides an 
estimate of non-primary registrations.
---------------------------------------------------------------------------

    \154\ DEA estimate based on registrations.
    \155\ Id.
    \156\ Bureau of Labor Statistics, Occupational Employment and 
Wages, May 2023 National Occupational Employment and Wage Estimates, 
https://www.bls.gov/oes/2023/may/oes_nat.htm. (accessed 10/18/2024). 
The following occupation codes were used: 29-1210 Physicians and 29-
1240 Surgeons (for ``physician''), 29-1171 Nurse Practitioners, and 
29-1071 Physician Assistants.
    \157\ IBISWorld. Telehealth Services in the US--Number of 
Businesses. February 15, 2024. https://www.ibisworld.com/industry-statistics/number-of-businesses/telehealth-services-united-states/ 
(accessed 4/20/2024).

[[Page 6575]]



                                      Table 17--Registrations by Occupation
----------------------------------------------------------------------------------------------------------------
                                     Number of       Number of     Registrations      Primary       Non-primary
           Occupation                employed       registrants    per employed    registrations   registrations
----------------------------------------------------------------------------------------------------------------
Physicians......................         770,850       1,122,940            1.46         770,850         352,090
Nurse Practitioner..............         280,140         403,748            1.44         280,140         123,608
Physician Assistant.............         145,740         168,201            1.15         145,740          22,461
                                 -------------------------------------------------------------------------------
    Total.......................       1,196,730       1,694,889            1.42       1,196,730         498,159
----------------------------------------------------------------------------------------------------------------
* Non-Primary Registrations figures are the differences between the Number of Registrants and Number of
  Employed.

    DEA believes covered online telemedicine platforms are best 
represented by telemedicine companies. IBISWorld estimates that as of 
2023 there were 1,306 such companies in the United States.\158\
---------------------------------------------------------------------------

    \158\ IBISWorld. Telehealth Services in the US--Number of 
Businesses. February 15, 2024. https://www.ibisworld.com/industry-statistics/number-of-businesses/telehealth-services-united-states/ 
(accessed 4/20/2024).
---------------------------------------------------------------------------

    Current Telemedicine Rate Estimate of Number of Registrations. 
According to the Fair Health Monthly Telehealth Regional Tracker, as of 
July 2024, 4.7 percent of medical claims were conducted through 
telehealth.\159\ There may be some variation in how Physicians, Nurse 
Practitioners, and Physician Assistants prescribe.\160\ Telemedicine 
prescribing also may not be at the exact same rate as in-person.\161\ 
However, given the uncertainty in the exact difference and for 
simplicity, DEA has assumed that each practitioner type prescribes at 
the same rate and uses telemedicine to prescribe at the same rate as 
in-person. DEA applied the `telemedicine rates' in Table 13 to the 
total number of employed physicians, nurse practitioners, and physician 
assistants to estimate the number of individual practitioner Special 
Registrations there will be under the proposed rule. Applying the 
`telemedicine rates' of 0.2 percent, 4.7 percent, and 13 percent to the 
total number of physicians, nurse practitioners, and physician 
assistants of 1,196,730, the estimated number of individual 
telemedicine prescribing registrations are 2,393, 56,246, and 155,575 
for low, moderate (primary), and high estimates, respectively.\162\ 
Using the 2023 IBISWorld estimate of telemedicine companies of 1,306 
provides an estimate of 1,306 Telemedicine Platform Registrations.\163\ 
The number of conventional registrations would then also be 1,306, in 
line with Telemedicine Platform Registrations. Applying the 
relationship between the low (0.2 percent), moderate (primary) (4.7 
percent), and high (13 percent) ``telemedicine rates'' to the moderate 
(primary) estimate of 1,306 Telemedicine Platform Registrations from 
IBISWorld, results in a low estimate of 56 (1,306 x (0.2/4.7)) and a 
high estimate of 3,612 (1,306 x (13/4.7)).
---------------------------------------------------------------------------

    \159\ Fair Health, ``Monthly Telehealth Regional Tracker.'' 
https://www.fairhealth.org/fh-trackers/telehealth. (accessed 10/19/
2024 selecting July 2024 using National Statistics data dropdown 
menu).
    \160\ Cipher DJ, Hooker RS, Guerra P. Prescribing trends by 
nurse practitioners and physician assistants in the United States. J 
Am Acad Nurse Pract. 2006 June. https://pubmed.ncbi.nlm.nih.gov/16719848/.
    \161\ Wabe N, Thomas J, Sezgin G, Sheikh MK, Gault E, Georgiou 
A. Medication prescribing in face-to-face versus telehealth 
consultations during the COVID-19 pandemic in Australian general 
practice: a retrospective observational study. BJGP Open. 2022 
March, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8958736/pdf/bjgpopen-6-0132.pdf.
    \162\ Employment was used because practitioner commonly have 
multiple conventional registrations to cover each practice location, 
but only need one special registration.
    \163\ IBISWorld. Telehealth Services in the US--Number of 
Businesses. Feb. 15, 2024. https://www.ibisworld.com/industry-statistics/number-of-businesses/telehealth-services-united-states/ 
(accessed 4/20/2024).
---------------------------------------------------------------------------

    Assuming the rate of registrants obtaining DEA registrations are in 
line with the rate of those that will obtain clinician State 
Telemedicine Registrations, DEA used 0.2 percent, 4.7 percent, and 13 
percent of the total number of registrations to provide the low, 
moderate (primary), and high estimates of how many clinician State 
Telemedicine Registrations there will be under the proposed rule. 
Multiplying the total number of registrations of 1,694,889 (from Table 
17) by 0.2 percent, 4.7 percent, and 13 percent, results in 3,390, 
79,660, and 220,336 clinician State Telemedicine Registrations for low, 
moderate (primary), and high estimates, respectively. Assuming a 
similar relationship holds for platforms, the number of platform State 
Telemedicine Registrations are estimated to be 42 percent (from Table 
17, 1.42 registrations per employed minus 1) higher than the level of 
Telemedicine Platform Registrations. However, platforms are expected to 
be registered in more states than clinician practitioners. Based on a 
DEA analysis of the distributions of other national registrant types, a 
rate of 10 times the clinician practitioner rate was chosen.\164\ The 
number of platform State Telemedicine Registrations is then estimated 
to be 420% (42% x 10) higher than the level of Telemedicine Platform 
Registrations, or 291 (56 x 5.20), 6,791 (1,306 x 5.20), and 18,782 
(3,612 x 5.20) for low, moderate (primary), and high estimates 
respectively. DEA estimates the number of special registrations would 
reach these levels in the first year of implementation of this proposed 
rule. Table 18 below summarizes the first-year numbers and growth rates 
of special registrations for the low, moderate (primary), and high 
estimates.
---------------------------------------------------------------------------

    \164\ DEA manufacturers and distributors with the most 
registrations have ten, with the median being one. Assuming 
platforms have a similar distribution, but have a max of 50, it 
would imply a median of five. This is approximately 10 times the 
clinician practitioner rate of 0.42.

                           Table 18--``Year 1'' Special Registrations and Growth Rates
----------------------------------------------------------------------------------------------------------------
                                                                                     Moderate
                                                                        Low          (primary)         High
----------------------------------------------------------------------------------------------------------------
``Telemedicine rate''...........................................           0.20%           4.70%          13.00%
Year 1 Patient Visits...........................................          20,309         477,264       1,320,092
Year 1 Telemedicine Prescribing-Individual......................           2,393          56,246         155,575
Year 1 State Telemedicine-Individual............................           3,390          79,660         220,336
Year 1 Conventional-Platform....................................              56           1,306           3,612

[[Page 6576]]

 
Year 1 Telemedicine Platform....................................              56           1,306           3,612
Year 1 State Telemedicine-Platform..............................             291           6,791          18,782
Year 1 Total Registrations......................................           6,186         145,309         401,917
Annual Growth Rate..............................................           2.00%           4.95%          19.00%
----------------------------------------------------------------------------------------------------------------

    Applying the growth rates to the `Year 1' registration figures, DEA 
generated 10-year forecasts for the low, moderate (primary), and high 
estimates as shown in Tables 19, 20, and 21 below.

                                        Table 19--Registrations Forecast (Low, 0.2 percent ``telemedicine rate'')
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Telemedicine        State                                           State
                          Year                              Growth rate    prescribing-    telemedicine-   Conventional-   Telemedicine    telemedicine-
                                                                (%)         individual      individual       platform        platform        platform
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.......................................................  ..............           2,393           3,390              56              56             291
2.......................................................               2           2,441           3,458              57              57             297
3.......................................................               2           2,490           3,527              58              58             303
4.......................................................               2           2,540           3,598              59              59             309
5.......................................................               2           2,591           3,670              60              60             315
6.......................................................               2           2,643           3,743              61              61             321
7.......................................................               2           2,696           3,818              62              62             327
8.......................................................               2           2,750           3,894              63              63             334
9.......................................................               2           2,805           3,972              64              64             341
10......................................................               2           2,861           4,051              65              65             348
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                Table 20--Registrations Forecast (Moderate (Primary), 4.7 Percent ``Telemedicine Rate'')
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Telemedicine            State
              Year                 Growth  rate  (%)     prescribing-        telemedicine-       Conventional-       Telemedicine     State telemedicine-
                                                          individual          individual           platform            platform             platform
--------------------------------------------------------------------------------------------------------------------------------------------------------
1...............................  ..................  56,246............  79,660............  1,306.............  1,306.............  6,791
2...............................  4.95..............  59,030............  83,603............  1,371.............  1,371.............  7,127
3...............................  4.95..............  61,952............  87,741............  1,439.............  1,439.............  7,480
4...............................  4.95..............  65,019............  92,084............  1,510.............  1,510.............  7,850
5...............................  4.95..............  68,237............  96,642............  1,585.............  1,585.............  8,239
6...............................  4.95..............  71,615............  101,426...........  1,663.............  1,663.............  8,647
7...............................  4.95..............  75,160............  106,447...........  1,745.............  1,745.............  9,075
8...............................  4.95..............  78,880............  111,716...........  1,831.............  1,831.............  9,524
9...............................  4.95..............  82,785............  117,246...........  1,922.............  1,922.............  9,995
10..............................  4.95..............  86,883............  123,050...........  2,017.............  2,017.............  10,490
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 6577]]


                                       Table 21--Registrations Forecast (High, 13.0 Percent ``Telemedicine Rate'')
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Telemedicine            State
              Year                 Growth  rate  (%)     prescribing-        telemedicine-       Conventional-       Telemedicine     State telemedicine-
                                                          individual          individual           platform            platform             platform
--------------------------------------------------------------------------------------------------------------------------------------------------------
1...............................  ..................  155,575...........  220,336...........  3,612.............  3,612.............  18,782
2...............................  19................  185,134...........  262,200...........  4,298.............  4,298.............  22,351
3...............................  19................  220,309...........  312,018...........  5,115.............  5,115.............  26,598
4...............................  19................  262,168...........  371,301...........  6,087.............  6,087.............  31,652
5...............................  19................  311,980...........  441,848...........  7,244.............  7,244.............  37,666
6...............................  19................  371,256...........  525,799...........  8,620.............  8,620.............  44,823
7...............................  19................  441,795...........  625,701...........  10,258............  10,258............  53,339
8...............................  19................  525,736...........  744,584...........  12,207............  12,207............  63,473
9...............................  19................  625,626...........  886,055...........  14,526............  14,526............  75,533
10..............................  19................  744,495...........  1,054,405.........  17,286............  17,286............  89,884
--------------------------------------------------------------------------------------------------------------------------------------------------------

    DEA also expects that State Telemedicine Registrations could 
potentially be much greater than this estimate given the fact that 
State Telemedicine Registrations will not require a physical location. 
However, based on an analysis done on Medicare beneficiaries using 2020 
data, only 5 percent of telemedicine takes place across state lines and 
most of this out-of-state care was for established patient care.\165\ 
To the extent established patient care was a practitioner-patient 
relationship established following an in-person medical evaluation it 
would also not be considered telemedicine per the proposed rule. 
Further, out of state telehealth represented only 0.8 percent of all 
visits.\166\ It is unclear how willing practitioners will be to 
register in multiple states to handle a very limited number of their 
patients who need telemedicine across state lines, and which represents 
such a small share of their total patient load. However, DEA believes 
these numbers could grow substantially based on having permanent 
telemedicine flexibilities in place around which practitioners can 
restructure their practices without comparable worry of future removal 
or expiration. This would be in line with an increasing number of 
practitioners working for platforms that serve a much broader 
geographical region compared to a typical physician office.
---------------------------------------------------------------------------

    \165\ Andino, J., Zhu, Z., Surapaneni, M., Dunn, R. L., & 
Ellimoottil, C. (2022). Interstate Telehealth Use by Medicare 
Beneficiaries Before and After COVID-19 Licensure Waivers, 2017-20. 
Health Affairs, 41(6).
    \166\ Id.
---------------------------------------------------------------------------

B. Practitioner and MLP Cost to Apply for Special Registration

    In order to estimate the time cost for applying for the 
conventional registration, Special Registration (Telemedicine 
Prescribing Registration and the Advanced Telemedicine Prescribing 
Registration, or the Telemedicine Platform Registration) and the State 
Telemedicine Registration (State Telemedicine for Individual Special 
Registrants or State Telemedicine for Platform Special Registrants), 
DEA used an estimate of the amount of time and the value of that time 
for a practitioner to apply for the registration. To calculate the 
labor cost of applying for either the conventional registration, 
Special Registration or the State Telemedicine Registration, DEA 
estimates that on average it will take ten minutes (0.17 hours) to 
complete the registration application.\167\ Should the application for 
a Special Registration or the State Telemedicine Registration be 
completed at the same time, the extra cost would be minimal. However, 
erring on the side of caution, DEA has assumed applications will be 
done separately and therefore has not made such a reduction.
---------------------------------------------------------------------------

    \167\ This estimate is based on the time required to complete 
the new DEA Form 224S and DEA Form 224S-M, which will be used as the 
application for a Special Registration for Telemedicine and State 
Telemedicine Registration.
---------------------------------------------------------------------------

    Typically, practitioners delegate the task of completing DEA 
registration applications to their medical office administration or 
secretarial staff, or they may opt to use a credentialing company. For 
this reason, DEA has used the BLS median hourly wages for Medical 
Secretaries and Administrative Assistants, occupational code 43-6013, 
of $19.54.\168\ Additionally, BLS reports that average wages and 
salaries for civilians are 69 percent of total compensation. The 68.8 
percent of total compensation equates to 45.3 percent (100 percent/68.8 
percent--1) load on wages and salaries.\169\ The load of 45.3 percent, 
or $8.85 (0.453 x $19.54), is added to the hourly rate to estimate the 
loaded hourly rates. As can be seen in Table 22, the loaded hourly wage 
for completing DEA registration applications is $28.39 ($19.54 + 
$8.85).
---------------------------------------------------------------------------

    \168\ Bureau of Labor Statistics, Occupational Employment and 
Wages, May 2023 National Occupational Employment and Wage Estimates, 
https://www.bls.gov/oes/2023/may/oes_nat.htm. (Accessed 10/18/2024).
    \169\ Bureau of Labor Statistics, Employer Costs for Employee 
Compensation -June 2024, https://www.bls.gov/news.release/archives/ecec_09102024.pdf. (accessed 10/18/2024).
---------------------------------------------------------------------------

    To calculate the labor cost of applying for either the Special 
Registration or the State Telemedicine Registration, DEA estimates that 
on average it will take ten minutes (0.17 hours) for an applicant to 
apply for any of them.\170\ The estimated labor cost to complete the 
application is $4.83 ($28.39 x 0.17). These registrations are for three 
years, so the annualized labor cost of registration is $1.61 ($4.83/3). 
This calculation is shown in Table 22 below.
---------------------------------------------------------------------------

    \170\ This estimate is based on the time required to complete 
DEA Form 224A, which would be modified to also be used as the 
application for the Special Registration for Telemedicine and State 
Telemedicine Registration.

                                                             Table 22--Per Application Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                            Annualized
                                                      Hourly  wage       Load for      Loaded  hourly    Application        Cost per         cost per
                    Occupation                            ($)         benefits  ($)      wage  ($)      time  (hours)     application      application
                                                                                                                              ($)              ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Secretaries and Administrative Assistants.           19.54             8.85            28.39             0.17             4.83             1.61
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 6578]]

C. Practitioner and MLP Cost to Report to DEA

    The proposed rule requires special registrants to report to DEA, on 
an annual basis, the total number of new patients in each state treated 
under their Special Registration for Telemedicine, the total number of 
prescriptions for Schedule II controlled substances issued by the 
special registrant, and the total number of prescriptions for qualified 
Schedule III-V controlled substances issued by the special registrant 
for the preceding year. The special registrant would be required to 
electronically report this data through the DEA Office of Diversion 
Control's secure network application.
    DEA believes the creation of this report by the registrant's 
electronic prescription controlled substance (EPCS) system will be a 
minimal one-time expense. EPCS systems already are required by CFR 
1311.120(b)(27)(i) to track controlled substance transactions. The new 
piece of data that will be needed for this to be fully automated is 
tracking which patients fall under the proposed rule's telemedicine 
requirements. DEA believes this can be added to these existing systems 
during routine operation and maintenance and tracked with minimal cost 
and effort.
    DEA believes the annual running of this report and submitting 
electronically to DEA can be done in six minutes (0.10 hours). Using 
the previously calculated loaded hourly wage for Medical Secretaries 
and Administrative Assistants of $28.39, the cost per report is $2.84 
($28.39 x 0.1), as can be seen in Table 23 below.

                                                                Table 23--Per Report Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Hourly wage        Load for      Loaded  hourly  Reporting  time      Cost per
                             Occupation                                    ($)         benefits  ($)      wage  ($)          (hours)       report  ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Secretaries and Administrative Assistants..................           19.54             8.85            28.39             0.10             2.84
--------------------------------------------------------------------------------------------------------------------------------------------------------

D. Practitioner and MLP Cost to Check PDMP per Visit

    The proposed rule immediately requires practitioners to complete a 
PDMP check of (1) the state/territory where the patient is located; (2) 
the state/territory where the practitioner is located; and (3) any 
state/territory with PDMP reciprocity agreements with either the state/
territory where the patient is located or the state/territory where the 
practitioner is located. With a delayed effective date of three years, 
it requires a PDMP review of all 50 states and any U.S. districts and 
territories that maintain a PDMP prior to issuing a telemedicine 
prescription under the Special Registration. While a single 
comprehensive system that can check all 50 states and any U.S. 
districts and territories that maintain a PDMP is not currently 
available, once that system is in place, DEA believes it will perform 
similarly to existing PDMP checks. Based on a 2018 study, it takes a 
practitioner 27 seconds to log in and 37 seconds to retrieve a report 
once logged in.\171\ The total time it takes to retrieve a PDMP report 
is roughly a minute (27 + 37 = 64 seconds) or 0.017 of an hour (1/60).
---------------------------------------------------------------------------

    \171\ Bachhuber MA, Saloner B, LaRochelle M, Merlin JS, Maughan 
BC, Polsky D, Shaparin N, Murphy SM. Physician Time Burden 
Associated with Querying Prescription Drug Monitoring Programs. Pain 
Med. 2018 Oct.
---------------------------------------------------------------------------

    From BLS data, DEA used the weighted average of the mean hourly 
wages for Physicians (occupation code 29-1210) and Surgeons (occupation 
code 29-1240) to represent the wages for all practitioners. For 
Physicians, the mean hourly wage and employment are $126.85 and 
716,950, and for Surgeons, the mean hourly wage and employment are 
$167.74 and 53,900; the weighted average of the median hourly wages is 
$129.71.\172\ DEA also used the average of the median hourly wages for 
Physician Assistants (occupation code 29-1071) of $62.51 and Nurse 
Practitioners (occupation code 29-1171) of $60.70 to represent the 
hourly wages of MLPs. As calculated earlier, a load of 45.3 for 
benefits is added to these wages to calculate loaded wages. The loaded 
wages for physicians, PAs, and NPs are $188.47 ($129.71 x 1.453), 
$90.83 ($62.51 x 1.453), and $88.20 ($60.70 x 1.453), respectively. The 
estimated labor cost to complete the review for physicians is $3.20 
($188.47 x 0.017), for physician assistants is $1.54 ($90.83 x 0.017), 
and for nurse practitioners is $1.50 ($88.20 x 0.017).
---------------------------------------------------------------------------

    \172\ Bureau of Labor Statistics, Occupational Employment and 
Wages, May 2023 National Occupational Employment and Wage Estimates, 
https://www.bls.gov/oes/2023/may/oes_nat.htm. (accessed 10/18/2024). 
Employment figures for Physicians and Surgeons are 716,950 and 
53,900, respectively, for a total of 770,850. Weighted average = 
$126.85 x (716,950/770,850) + $167.74 x (53,900/770,850) = $129.71.

                                         Table 24--PDMP Check Time Cost
----------------------------------------------------------------------------------------------------------------
                                   Hourly  wage      Load for     Loaded  hourly    PDMP  check   Cost per  PDMP
           Occupation                   ($)        benefits  ($)     wage  ($)     time  (hours)     check  ($)
----------------------------------------------------------------------------------------------------------------
Physicians......................          129.71           58.76          188.47           0.017            3.20
Physician Assistants............           62.51           28.32           90.83           0.017            1.54
Nurse Practitioners.............           60.70           27.50           88.20           0.017            1.50
----------------------------------------------------------------------------------------------------------------

    For simplicity, DEA calculated a single cost of a PDMP check based 
on the weighted average of the three occupations. Using the `Number of 
Registrants' from Table 17 to calculate weights, the weighted average 
of the PDMP check is $2.63.\173\
---------------------------------------------------------------------------

    \173\ The number of physician, physician assistant, and nurse 
practitioner registrants are 1,122,940, 168,201, and 403,748, 
respectively, for a total of 1,694,889. The weighted average is 
$3.20 x (1,122,940/1,694,889) + $1.54 x (168,201/1,694,889) + $1.50 
x (403,748/1,694,889) = $2.63.
---------------------------------------------------------------------------

    Recordkeeping and Infrastructure Costs. This proposed rule requires 
practitioners to maintain records relating to the Special Registration 
for Telemedicine. DEA believes that the recordkeeping requirements 
related to the Special Registration for Telemedicine will not impose 
major

[[Page 6579]]

additional costs on registrants. Practitioners who prescribe using a 
Special Registration would face additional recordkeeping requirements; 
but, given that the photographic record, Special Registration 
telemedicine encounter record, credential verification and conduct-
related recordkeeping, and centralized recordkeeping required by 
proposed 21 CFR 1304.04(i)-(l) is not extensive, DEA does not 
anticipate it imposes a major burden on registrants. DEA also examined 
the cost of technology for telemedicine, both capital investment and 
operational expenses, in order to operate under the proposed Special 
Registration for Telemedicine framework. DEA believes that these 
initial investments have already been made by the practitioners most 
likely to apply for the Special Registration for Telemedicine and that 
there will be no additional technology or infrastructure cost to these 
practitioners to use the Special Registration for Telemedicine.

E. Practitioner and MLP Total Costs; Cost Savings

    Total Cost. As mentioned previously, the three types of costs to 
practitioners are: (1) registration time costs, (2) reporting time 
costs, and (3) PDMP check costs. In summary, these costs are listed in 
Table 25 below.

                       Table 25--Unit Cost Summary
------------------------------------------------------------------------
                                                            Unit costs
------------------------------------------------------------------------
Registration application labor cost, annualized (applies            1.61
 to all registrations)..................................
Reporting cost (applies to the number of primary special            2.84
 registration)..........................................
PDMP check cost (applies to all visit)..................            2.63
------------------------------------------------------------------------

    Unlike patient travel time and cost savings, since the PDMP check 
is required for all visits and not just first-time visits, there will 
not be a first-time visit adjustment. While PDMP checks will be 
required for all special registration prescriptions under this proposed 
rule, many practitioners already conduct PDMP checks. Due to a 
combination of the following factors, this would lower the additional 
burden imposed by this proposed rule:
    (1) 45 out of 50 states require PDMP checks in some form,\174\
---------------------------------------------------------------------------

    \174\ DrFirst. State Mandates Driving EPCS and PDMP Utilization. 
https://drfirst.com/resources/regulatory-mandates/ (Accessed 11/2/
2023).
---------------------------------------------------------------------------

    (2) Some states, such as California and New York, require PDMP 
checks for Schedule II-IV drugs (excluding Schedule V),\175\
---------------------------------------------------------------------------

    \175\ New York State Department of Health. Frequently Asked 
Questions for the NYS PMP. June 2017. https://www.health.ny.gov/professionals/narcotic/prescription_monitoring/docs/pmp_registry_faq.pdf (Accessed 11/2/2023), and Health Services 
Advisory Group. California's Prescription Drug Monitoring Program 
(PDMP). https://hsag.com/contentassets/d1483fc74ad34b60b14cc1116e8cb14c/surscapdmpworkflow2020508.pdf 
(Accessed 11/2/2023).
---------------------------------------------------------------------------

    (3) Other states have requirements that focus on the initial visit 
and do not always require checks for all follow-up visits.\176\
---------------------------------------------------------------------------

    \176\ Id.
---------------------------------------------------------------------------

    (4) Compliance with existing state laws is not 100 percent and the 
proposed rule may have an impact, but there will also be instances of 
non-compliance.\177\
---------------------------------------------------------------------------

    \177\ Delcher C, Pauly N, Moyo P. Advances in prescription drug 
monitoring program research: a literature synthesis (June 2018 to 
December 2019). Curr Opin Psychiatry. 2020 Jul.
---------------------------------------------------------------------------

    However, to be conservative, DEA applied the full cost of $2.63 to 
all telemedicine visits leading to a special registration prescription 
by backing out the 0.1 factor applied for first-time visits in Table 8, 
in other words by multiplying the number of first-time telemedicine 
visits (Table 11) under the proposed rule with controlled substance 
prescriptions by 10. The proposed rule intends for there to be a 
nationwide PDMP that would allow for one PDMP check per visit. However, 
until such a system is put in place, for the first three years 
practitioners will only be required under the proposed rule to check 
the state location of the patient, the state location of the 
practitioner, and all states with reciprocity agreements with either of 
those two states. This could increase the number of checks per visit to 
two for some practitioners.
    However, patients and practitioners may be in the same state. Also, 
based on a September 2023 analysis done by DEA of state PDMP 
participation, the average state, including the District of Columbia, 
only shares PDMP data with 30 other states.\178\ Both factors could 
substantially reduce the number of PDMP checks from two to something 
much closer to one. For simplicity, DEA will assume there will be only 
one PDMP check required, in line with its long-term expectation.
---------------------------------------------------------------------------

    \178\ Data from Pdmpassist.org (Accessed September 2023).
---------------------------------------------------------------------------

    Applying the annualized registration application labor cost of 
$1.61 to the number of registrations in Table 19, 20, and 21, the 
reporting cost of $2.84 to the number of primary (non-state) special 
registrations in Table 19, 20, and 21, and the PDMP check cost of $2.63 
to all telemedicine visits that result in a controlled substances 
prescription (10 times the number of first-time visits from Table 15), 
the 10-year cost forecast is shown in Tables 26, 27, and 28 below for 
the low, moderate (primary), and high estimates.

                                 Table 26--Total Practitioner and MLP Cost (Low)
----------------------------------------------------------------------------------------------------------------
                                                                   Registration
                                                                    application      Reporting      PDMP  check
                              Year                                  labor cost       cost  ($)       cost  ($)
                                                                        ($)
----------------------------------------------------------------------------------------------------------------
1...............................................................           9,959           6,955         534,127
2...............................................................          10,159           7,094         544,805
3...............................................................          10,362           7,236         555,693
4...............................................................          10,570           7,381         566,818
5...............................................................          10,781           7,529         578,153
6...............................................................          10,995           7,679         589,725
7...............................................................          11,214           7,833         601,507
8...............................................................          11,437           7,989         613,526
9...............................................................          11,666           8,148         625,809
10..............................................................          11,898           8,310         638,327
Present Value *.................................................          97,631          68,185       5,236,494

[[Page 6580]]

 
Annualized Cost *...............................................          10,869           7,591         582,961
----------------------------------------------------------------------------------------------------------------
* Present value and annualized values are based on a two percent (2%) discount rate.


                          Table 27--Total Practitioner and MLP Cost (Moderate--Primary)
----------------------------------------------------------------------------------------------------------------
                                                                   Registration
                                                                    application      Reporting      PDMP  check
                              Year                                  labor cost       cost  ($)       cost  ($)
                                                                        ($)
----------------------------------------------------------------------------------------------------------------
1...............................................................         233,947         163,448      12,552,043
2...............................................................         245,528         171,539      13,173,381
3...............................................................         257,682         180,030      13,825,463
4...............................................................         270,437         188,942      14,509,815
5...............................................................         283,824         198,294      15,228,042
6...............................................................         297,873         208,110      15,981,826
7...............................................................         312,617         218,410      16,772,930
8...............................................................         328,089         229,219      17,603,195
9...............................................................         344,331         240,568      18,474,540
10..............................................................         361,376         252,476      19,389,018
Present Value *.................................................       2,616,334       1,827,907     140,374,966
Annualized Cost *...............................................         291,267         203,495      15,627,458
----------------------------------------------------------------------------------------------------------------
* Present value and annualized values are based on a two percent (2%) discount rate.


                                Table 28--Total Practitioner and MLP Cost (High)
----------------------------------------------------------------------------------------------------------------
                                             Registration
                 Year                  application  labor cost    Reporting  cost  ($)    PDMP  check  cost  ($)
                                                  ($)
----------------------------------------------------------------------------------------------------------------
1....................................  647,086................  452,091................  34,718,420
2....................................  770,032................  537,987................  41,314,907
3....................................  916,340................  640,204................  49,164,747
4....................................  1,090,445..............  761,844................  58,506,060
5....................................  1,297,631..............  906,596................  69,622,202
6....................................  1,544,180..............  1,078,848..............  82,850,418
7....................................  1,837,575..............  1,283,831..............  98,591,994
8....................................  2,186,713..............  1,527,758..............  117,324,484
9....................................  2,602,188..............  1,818,032..............  139,616,127
10...................................  3,096,603..............  2,163,458..............  166,143,202
Present Value *......................  13,975,657.............  9,764,161..............  749,841,038
Annualized Cost *....................  1,555,861..............  1,087,010..............  83,477,199
----------------------------------------------------------------------------------------------------------------
* Present value and annualized values are based on a two percent (2%) discount rate.

    Cost Savings. The following sections summarize the expected cost 
savings related to the Special Registration for Telemedicine and State 
Telemedicine Registration that are realized by practitioners. As 
discussed in the healthcare system section, there may not be a cost 
savings on the healthcare system side based on an evaluation of health 
care systems.\179\ While practitioners may be able to reduce travel to 
and from the office, this time savings is likely much less than 
patients since practitioners may still go to the office and may see 
many patients, each of whom would be saving travel time. Practitioners 
may also become more available to patients which may offset any travel 
time and cost savings. In line with this, DEA believes the net cost 
savings for practitioners will be $0.
---------------------------------------------------------------------------

    \179\ Snoswell CL, Taylor ML, Comans TA, Smith AC, Gray LC, 
Caffery LJ. Determining if Telehealth Can Reduce Health System 
Costs: Scoping Review. J Med internet Res. Oct 19, 2020.
---------------------------------------------------------------------------

F. Practitioner and MLP Transfers

    The following sections summarize the changes in transfers related 
to the expected new conventional registrations, the Special 
Registration for Telemedicine (Telemedicine Prescribing Registration, 
the Advanced Telemedicine Prescribing Registration and Telemedicine 
Platform Registration) and the State Telemedicine Registration (State 
Telemedicine for Individual Special Registrants and State Telemedicine 
for Platform Special Registrants) realized by practitioners. As 
discussed earlier, registrations fees paid to DEA are considered to be 
``transfers.''
    DEA proposes to set Special Registration fees to recover the cost 
of administering the registrations and operating the diversion control 
aspect of the proposed new business activities. Due to a myriad of 
unknowns, DEA is unable to calculate a cost that would need to be 
recovered. Therefore, DEA proposed to set the State Telemedicine

[[Page 6581]]

for Individual Special Registration fee at $50 per three years and 
other Special Registration fees at the same rate as the ``dispensing or 
instructing'' business activity (currently $888 per three years) as 
discussed further below. 21 CFR 1301.13(e)(1)(iv). Other than the State 
Telemedicine for Individual Special Registration, the Special 
Registration provides authority to dispense controlled substances 
similar to the various registrants in the ``dispensing or instructing'' 
business activity. DEA's cost of administering the registrations and 
operating the diversion control aspect of the Special Registrations are 
expected to be similar to that of registrations in the ``dispensing or 
instructing'' business activity.
    Conventional Registration Transfers. In order to prescribe 
controlled substances using a Special Registration for Telemedicine, 
practitioners generally must have three registrations. First, a 
practitioner must be registered under 21 U.S.C. 823(g), i.e. a 
conventional registration, unless exempt from requirement of 
registration pursuant to 21 CFR 1301.23(a). The fee for such 823(g) 
registrations, ``dispensing or instructing'' business activity, is 
currently $888 for a three-year cycle ($296/year) pursuant to 21 CFR 
1301.13(e)(1)(iv), unless exempt from fees pursuant to 21 CFR 
1301.21(a). Unless subject to an exemption, all clinician practitioners 
that prescribe or dispense controlled substances must have this 
registration; therefore, the proposed rule does not impact this 
registration category or fee for clinician practitioners.
    Covered online telemedicine platforms must also be registered as 
practitioners. DEA applied the annualized registration fee calculated 
previously of $296 to the number of conventional registrations from 
Tables 19, 20, and 21 to estimate the conventional registration 
transfers for low, moderate (primary), and high estimates.
    Special Registration Transfers. The proposed rule adds two new DEA 
registrations (and fees) that practitioners must obtain: a Special 
Registration for Telemedicine (either the Telemedicine Prescribing 
Registration, the Advanced Telemedicine Prescribing Registration and 
Telemedicine Platform Registration), and State Telemedicine 
Registrations (State Telemedicine for Individual Special Registrants 
and State Telemedicine for Platform Special Registrants).\180\
---------------------------------------------------------------------------

    \180\ A non-VA practitioner would not be required to have a 21 
U.S.C. 823(g)registration in his or her own State or a State 
Telemedicine Registration in the patient's state if exempt from 
registration in all States under DEA regulations. See 21 U.S.C. 
831(h)(1)(B)(i), proposed 21 CFR 1301.61(b)(4).
---------------------------------------------------------------------------

    As discussed earlier, DEA proposes to set the fee for the 
individual Special Registration for Telemedicine (Telemedicine 
Prescribing Registration and Advanced Telemedicine Prescribing 
Registration) at the same fee as the ``dispensing or instructing'' 
business activity, currently $888 per three years pursuant to 21 CFR 
1301.13(e)(1)(iv). For now, DEA proposes to set the registration fee 
for Platform Special Registrants at the same fee as the Individual 
Special Registrants and registrants under the conventional registration 
of institutions, such as hospitals and clinics. As DEA gathers more 
data (such as pharmacy and practitioner reports included in this 
proposed rule) on the burden DEA incurs from Platform Special 
Registrants, this fee will be reevaluated. DEA applied the annualized 
registration fee of $296 to the number of Special Registrations, 
labeled ``Telemedicine Prescribing-Individual'' (which includes 
``Telemedicine Prescribing'' and ``Advanced Telemedicine Prescribing'' 
registrations) and ``Telemedicine Platform'' in Tables 19, 20, and 21, 
to estimate the primary special registration transfers for low, 
moderate (primary), and high estimates.
    State Telemedicine Registration Transfers. It is also statutorily 
required that a practitioner ``is registered under section 823(g) of 
this title in the State in which the patient will be located when 
receiving the telemedicine treatment. . . .'' 21 U.S.C. 831(h)(B). 
Therefore, the proposed rule would create the State Telemedicine 
Registration (State Telemedicine for Individual Special Registrants and 
State Telemedicine for Platform Special Registrants) to satisfy this 
requirement.
    Registration fees generally cover two primary costs: (1) costs 
associated with processing and administering registrations, and (2) 
costs associated with general oversight and enforcement of controlled 
substance laws and regulations. The State Telemedicine for Individual 
Special Registration is an ancillary registration to the Special 
Registration and DEA proposes to set the fee at a level to recover 
DEA's cost of processing and administering the registration only. Based 
on an internal DEA 2021 study, as can be seen in Table 29 below, the 
total annual registration cost to DEA was $28,930,063.\181\ This 
equates to a registration cost per registration of $45.\182\
---------------------------------------------------------------------------

    \181\ This includes the annual cost of labor to process 
registrations ($17,107,968), the annual cost of labor to conduct 
liability pre-registration investigations ($2,955,422), and the 
annual cost to maintain the registration IT system ($8,866,672). 
Figures are rounded as shown.
    \182\ Dividing the total annual cost of $28,930,063 by the 
average number of new registrations and registration renewals 
processed annually from FY2018 to FY2020 of 645,734 yields a per 
registration cost of $45 (rounded). Practitioners pay this 
registration fee on a triennial basis.

                     Table 29--Historical Registration Cost of Conventional DEA Registration
----------------------------------------------------------------------------------------------------------------
                                                                                                     Cost per
                     Annual cost categories                         Annual cost    Registrations   registration
                                                                        ($)          per year           ($)
----------------------------------------------------------------------------------------------------------------
Labor cost of processing registrations..........................      17,107,968         645,734           26.49
Labor cost of pre-registration investigations...................       2,955,422         645,734            4.58
Cost to maintain the registration IT system.....................       8,866,672         645,734           13.73
Total...........................................................      28,930,062  ..............              45
----------------------------------------------------------------------------------------------------------------

    Adjusting the $45 cost for inflation, from 2020 to current (end of 
2023) dollars, the current estimated cost to process and administer a 
registration is $50.\183\ Since the registration is a three-year 
registration, the annualized registration fee is $17 ($50/3).
---------------------------------------------------------------------------

    \183\ Office of Management and Budget, Historical Tables, Table 
10.1-Gross Domestic Product and Deflators Used in the Historical 
Tables: 1940-2029. https://www.whitehouse.gov/omb/budget/historical-tables. (https://www.whitehouse.gov/wp-content/uploads/2024/03/hist10z1_fy2025.xlsx). (Accessed November 1, 2024). Using the ``GDP 
(Chained) Price Index'' of 1.05547 for 2020 and 1.2207 for 2023, $45 
in 2020 is adjusted for inflation to $52 ($45 x 1.2207/1.0547) in 
2023. $52 is rounded down to $50.
---------------------------------------------------------------------------

    The cost to DEA of administering the platform State Telemedicine 
Registration (State Telemedicine for Platform Special Registrants) is 
not

[[Page 6582]]

limited to the marginal registration cost. An individual doctor's time 
is finite, whether they are serving patients in one state or multiple 
states. However, for a platform there can be a much greater number of 
patients, number of doctors, and risk of diversion given the broader 
scope of practice as compared to an individual practitioner. Each 
additional state creates access to a new pool of patients and a 
diversion risk that cannot be fully covered from the fees from the 
Telemedicine Platform Registration and other State Telemedicine for 
Platform Special Registrations. DEA is proposing a $888 platform State 
Telemedicine Registration (State Telemedicine for Platform Special 
Registrants) fee with an annual rate over three years of $296 (888/3). 
Three-year registration fees and annualized fees are summarized in 
Table 30 below.

      Table 30--Registration Fees and Annualized Registration Fees
------------------------------------------------------------------------
                                                            Annualized
                                           Registration    registration
                                           fee/transfer    fee/transfer
                                                ($)             ($)
------------------------------------------------------------------------
Telemedicine Prescribing-Individual.....             888             296
State Telemedicine-Individual...........              50              17
Conventional-Platform...................             888             296
Telemedicine Platform...................             888             296
State Telemedicine-Platform.............             888             296
------------------------------------------------------------------------

    As with the Telemedicine Platform Registration fee, as DEA gathers 
more data (such as from pharmacy and practitioner reporting included in 
this proposed rule) on the burden from these registrants this fee may 
be adjusted in the future. DEA applied the annualized registration fee 
of $17 to the number of individual state registrations and the 
annualized registration fee of $296 to the number of platform state 
registrations from Tables 19, 20, and 21 to estimate the state 
registration transfers for low, moderate (primary), and high estimates.
    Furthermore, based on review of DEA's registration data, 
approximately 8.2 percent of physicians, nurse practitioners, and 
physician assistants are exempt from paying registration fees. 
Therefore, a factor of 91.8 percent (100 - 8.2) was applied to the 
number of individual primary and state registrations to estimate the 
number of fee-paying registrations. The annualized fees and fee-paying 
percentages for the various registrations are summarized in Table 31 
below.

    Table 31--Annualized Registration Fees and Fee-Paying Percentages
------------------------------------------------------------------------
                                            Annualized
                                           registration
                                           fee/transfer     Fee paying
                                                ($)
------------------------------------------------------------------------
Telemedicine Prescribing-Individual.....             296           91.8%
State Telemedicine-Individual...........              17           91.8%
Conventional-Platform...................             296            100%
Telemedicine Platform...................             296            100%
State Telemedicine-Platform.............             296            100%
------------------------------------------------------------------------

    Summary of Practitioner Transfers. Applying the annualized 
registration fees and fee-paying percentages (Table 31) to the number 
of registrations from Table 19, 20, and 21, results in registration fee 
transfers as shown in Tables 32, 33, and 34 for low, moderate 
(primary), and high estimates respectively.

                                Table 32--Total Transfer Payments by Registration
                                                      [Low]
----------------------------------------------------------------------------------------------------------------
                                   Telemedicine        State                                           State
              Year                 prescribing-    telemedicine-   Conventional-   Telemedicine    telemedicine-
                                  individual ($)  individual ($)   platform ($)    platform ($)    platform ($)
----------------------------------------------------------------------------------------------------------------
1...............................         650,245          51,867          16,576          16,576          86,136
2...............................         663,288          52,907          16,872          16,872          87,912
3...............................         676,603          53,963          17,168          17,168          89,688
4...............................         690,189          55,049          17,464          17,464          91,464
5...............................         704,047          56,151          17,760          17,760          93,240
6...............................         718,177          57,268          18,056          18,056          95,016
7...............................         732,579          58,415          18,352          18,352          96,792
8...............................         747,252          59,578          18,648          18,648          98,864
9...............................         762,197          60,772          18,944          18,944         100,936
10..............................         777,414          61,980          19,240          19,240         103,008
Present Value *.................       6,376,680         508,519         160,426         160,426         844,385

[[Page 6583]]

 
Annualized Cost *...............         709,894          56,612          17,860          17,860          94,002
----------------------------------------------------------------------------------------------------------------
* Present value and annualized values are based on a two percent (2%) discount rate.


                                Table 33--Total Transfer Payments by Registration
                                               [Moderate--Primary]
----------------------------------------------------------------------------------------------------------------
                                   Telemedicine        State                                           State
              Year                 prescribing-    Telemedicine-   Conventional-   Telemedicine    telemedicine-
                                  individual ($)  Individual ($)   platform  ($)   platform  ($)   platform ($)
----------------------------------------------------------------------------------------------------------------
1...............................      15,283,613       1,218,798         386,576         386,576       2,010,136
2...............................      16,040,104       1,279,126         405,816         405,816       2,109,592
3...............................      16,834,093       1,342,437         425,944         425,944       2,214,080
4...............................      17,667,483       1,408,885         446,960         446,960       2,323,600
5...............................      18,541,904       1,478,623         469,160         469,160       2,438,744
6...............................      19,459,801       1,551,818         492,248         492,248       2,559,512
7...............................      20,423,076       1,628,639         516,520         516,520       2,686,200
8...............................      21,433,905       1,709,255         541,976         541,976       2,819,104
9...............................      22,495,002       1,793,864         568,912         568,912       2,958,520
10..............................      23,608,544       1,882,665         597,032         597,032       3,105,040
Present Value *.................     170,923,255      13,630,288       4,323,434       4,323,434      22,480,387
Annualized Cost *...............      19,028,293       1,517,413         481,313         481,313       2,502,663
----------------------------------------------------------------------------------------------------------------
* Present value and annualized values are based on a two percent (2%) discount rate.


                                Table 34--Total Transfer Payments by Registration
                                                     [High]
----------------------------------------------------------------------------------------------------------------
                                   Telemedicine        State
                                   prescribing-    telemedicine-   Conventional-   Telemedicine        State
              Year                  individual      individual     platform  ($)   platform  ($)   telemedicine-
                                        ($)             ($)                                        platform  ($)
----------------------------------------------------------------------------------------------------------------
1...............................      42,274,084       3,371,141       1,069,152       1,069,152       5,559,472
2...............................      50,306,092       4,011,660       1,272,208       1,272,208       6,615,896
3...............................      59,864,124       4,773,875       1,514,040       1,514,040       7,873,008
4...............................      71,238,386       5,680,905       1,801,752       1,801,752       9,368,992
5...............................      84,773,701       6,760,274       2,144,224       2,144,224      11,149,136
6...............................     100,880,650       8,044,725       2,551,520       2,551,520      13,267,608
7...............................     120,048,072       9,573,225       3,036,368       3,036,368      15,788,344
8...............................     142,857,192      11,392,135       3,613,272       3,613,272      18,788,008
9...............................     170,000,102      13,556,642       4,299,696       4,299,696      22,357,768
10..............................     202,300,137      16,132,397       5,116,656       5,116,656      26,605,664
Present Value *.................     913,025,030      72,809,126      23,092,483      23,092,483     120,077,218
Annualized Cost *...............     101,643,906       8,105,587       2,570,806       2,570,806      13,367,780
----------------------------------------------------------------------------------------------------------------
* Present value and annualized values are based on a two percent (2%) discount rate.

G. Summary of Practitioner Costs, Cost Savings, Benefits, and Transfers

    The costs to practitioners and MLPs and registration fees 
(transfers) are summarized in Table 35 below.

[[Page 6584]]



                                              Table 35--Summary of Practitioner and MLP Costs and Transfers
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Low                     Moderate  (primary)                    High
                                                         -----------------------------------------------------------------------------------------------
                                                              Cost to                         Cost to                         Cost to
                          Year                             practitioners   Transfers  ($   practitioners   Transfers  ($   practitioners   Transfers ($
                                                           and MLPS  ($      million)      and MLPs  ($      million)      and MLPs  ($      million)
                                                             million)                        million)                        million)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.......................................................            0.55            0.82              13              19              36              53
2.......................................................            0.56            0.84              14              20              43              63
3.......................................................            0.57            0.85              14              21              51              76
4.......................................................            0.58            0.87              15              22              60              90
5.......................................................            0.60            0.89              16              23              72             107
6.......................................................            0.61            0.91              16              25              85             127
7.......................................................            0.62            0.92              17              26             102             151
8.......................................................            0.63            0.94              18              27             121             180
9.......................................................            0.65            0.96              19              28             144             215
10......................................................            0.66            0.98              20              30             171             255
Present Value *.........................................            5.40            8.05             145             216             774           1,152
Annualized Cost **......................................            0.60            0.90              16              24              86             128
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Present value and annualized values are based on a two percent (2%) discount rate.
** Figures are rounded as shown.

IV. Pharmacy Costs

    Under the proposed rule, pharmacies would be required to submit 
monthly reports in accordance with proposed Sec.  1304.60. DEA assumes 
similar reports are already being submitted to state PDMPs 
electronically and pharmacies would be able to submit reports as 
required by Sec.  1304.60 with minimal additional costs.

V. Healthcare System Costs and Cost Savings

    Based on the available research, DEA anticipates that there will be 
no significant net economic impact on healthcare systems due to the 
proposed rule. According to one peer-reviewed medical journal article 
from 2020, telehealth is expected to reduce costs in health systems 
between 32 percent to 53 percent of the time. However, evidence 
suggests that it does not routinely reduce the cost of care delivery 
for the health system as a whole.\184\ A more recent 2023 study, 
focused on payment analysis for telehealth and in-person care, comes to 
a similar conclusion, noting the lack of cost differential and 
concluding that the primary benefit of telehealth is increased access 
and convenience, not cost savings.\185\
---------------------------------------------------------------------------

    \184\ Snoswell CL, Taylor ML, et al. Determining if Telehealth 
Can Reduce Health System Costs: Scoping Review. J Med internet Res. 
October 2020.
    \185\ Amin K, Rae M, et al. Early in the pandemic, private 
insurer payments for telehealth and in-person claims were similar. 
Peterson-KFF Health System Tracker. January 18, 2023; and https://www.healthsystemtracker.org/brief/telehealth-payments-similar-early-in-the-pandemic/#Average%20payment%20for%20evaluation%20and%20management%20professional%20claims%20by%20telehealth%20and%20in-person,%20among%20privately%20insured,%202020 (Accessed 9/5/2023).
---------------------------------------------------------------------------

VI. State Costs

    The proposed rule immediately requires practitioners to complete a 
PDMP check of: (1) the state/territory where the patient is located; 
(2) the state/territory where the practitioner is located; and (3) any 
state/territory with PDMP reciprocity agreements with either the state/
territory where the patient is located or the state/territory where the 
practitioner is located. However, three years after the proposed rule's 
effective date, in order for Schedule II prescribing to continue across 
state lines, DEA is requiring that practitioners conduct PDMP checks 
for patients in all 50 states and any U.S. districts and territories 
that maintain a PDMP. Based on a September 2023 analysis conducted by 
DEA of State PDMP participation, the average state, including the 
District of Columbia, only shares PDMP data with 30 other states, as 
can be seen in Table 36.\186\ Based on that study, California was the 
only state that does not share data with any other state or a U.S. 
district and territory. However, California now does share PDMP data 
with Oregon. Guam and Northern Mariana Islands both share with Nebraska 
and each other. Puerto Rico shares with 30 states plus the District of 
Columbia.
---------------------------------------------------------------------------

    \186\ Data from Pdmpassist.org (Accessed September 2023).

   Table 36--PDMP Sharing Among 50 States and the District of Columbia
------------------------------------------------------------------------
                                                             Number of
                                                          states sharing
                                                               with
------------------------------------------------------------------------
Minimum.................................................               1
Minimum*................................................              10
Average.................................................              30
Median..................................................              32
Maximum.................................................              45
------------------------------------------------------------------------
* Excluding California.

    This is a significant improvement since practitioners first gained 
access to PDMPs in 1990 and electronic sharing of PDMP data was started 
in 2010.\187\ Further, most states use the same PDMP interconnectivity 
hub, with the two primary ones being PMP InterConnect and RxCheck.\188\ 
However, even with these improvements and similarities, ``there are 
some variances when it comes to data sharing and integration (i.e., 
assigned user roles, patient matching methods, percentage of provider 
population integrated, retention of PDMP data or reports) that pose 
challenges'' according to a report by the Prescription Drug Monitoring 
Program Training and Technical Assistance Center.\189\
---------------------------------------------------------------------------

    \187\ Interstate PDMP Access and Data Sharing Alignment, 
Prescription Drug Monitoring Program Training and Technical 
Assistance Center (Jan. 2021), https://www.pdmpassist.org/pdf/resources/Interstate_PDMP_Access_and_Data_Sharing_Alignment_20210125.pdf 
(Accessed October 23, 2023).
    \188\ Data from Pdmpassist.org (Accessed October 2023).
    \189\ Interstate PDMP Access and Data Sharing Alignment, 
Prescription Drug Monitoring Program Training and Technical 
Assistance Center (Jan. 2021), https://www.pdmpassist.org/pdf/resources/Interstate_PDMP_Access_and_Data_Sharing_Alignment_20210125.pdf 
(Accessed October 23, 2023).

---------------------------------------------------------------------------

[[Page 6585]]

    DEA does not have a basis to determine what the cost and 
coordination hurdles are in trying to implement 50-state sharing of 
PDMP data or how much more PDMP data sharing would have happened 
without this rule. Based on a 2016 study, there is evidence that states 
who have implemented PDMPs had a decline in the rate of opioid-related 
deaths in the year after their inauguration and that those declines 
were strongest in states whose PDMPs had the most comprehensive and 
efficient features, such as more frequently updated data.\190\ DEA 
believes increased state sharing will produce similar results and that 
any costs associated with implementation will be surpassed by the 
benefit of lower opioid-related deaths.
---------------------------------------------------------------------------

    \190\ Patrick, S.W., Fry, C.E., Jones, T.F., & Buntin, M.B. 
(2016). Implementation of prescription drug monitoring programs 
associated with reductions in opioid-related death rates. Health 
Affairs, 35(7), 1324-1332.
---------------------------------------------------------------------------

    From 2012 to 2016, SAMHSA funded projects across nine states to, 
among other things, increase PDMP access across states.\191\ Based on a 
report from the CDC, these projects were successful in increasing 
interstate PDMP data sharing, and this sharing brought about a decrease 
in prescription opioid abuse. Accordingly, there is reason for optimism 
that states can implement sharing and that outside groups can have a 
positive impact as well. This proposed rule would not create any 
mandate for states. Any costs incurred in PDMP data sharing among 
states are incurred outside of this rule. Therefore, any cost to states 
as a result of this rule would be minimal.
---------------------------------------------------------------------------

    \191\ Integration & Expanding Prescription Drug Monitoring 
Program Data: Lessons from Nine States, CDC (Feb. 2017), https://www.cdc.gov/drugoverdose/pdf/pehriie_report-a.pdf (Accessed 10/23/
2023).
---------------------------------------------------------------------------

VII. Diversion

    Requiring an in-person medical evaluation serves as a safeguard 
against diversion, consistent with the Ryan Haight Act. Certain signs 
of diversion or misuse of controlled substances may go undetected 
without an in-person assessment, as some indicators are either 
essential to observe personally or are more reliably detected when 
face-to-face. Without this safeguard, new diversion paradigms have 
emerged in telemedicine.\192\ Therefore, in the absence of an in-person 
medical evaluation requirement, DEA believes that other anti-diversion 
safeguards--such as those proposed in this NPRM--are necessary, beyond 
the measures that have been in place since March 2020, to address the 
ongoing risks of diversion.
---------------------------------------------------------------------------

    \192\ See, e.g., 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.
---------------------------------------------------------------------------

    Admittedly, there is little quantified data on diversion since the 
onset of the COVID-19 pandemic. However, the intentionally concealed 
and frequently underreported nature of drug diversion makes these 
illicit activities inherently difficult to track.\193\ By design, 
illegal activities like diversion are meant to evade detection, which 
complicates the collection of comprehensive and reliable quantitative 
data. Furthermore, diversion of controlled substances can take on many 
forms, from theft and fraud to improper prescribing making it difficult 
to quantify in a standardized method. Arguably, data shedding more 
light on diversion rates could be pulled from state PDMPs; however, as 
discussed above, the fragmented nature of PDMPs across the states fails 
to provide a comprehensive set of standardized data.
---------------------------------------------------------------------------

    \193\ In some comments to the March 2023 NPRMs and during some 
of the presentations during the Telemedicine Listening Sessions, 
individuals cited studies demonstrating a lack of increased 
proportion of overdose deaths involving buprenorphine during the 
initial months of the pandemic, when the telemedicine flexibilities 
were first put in place, as evidence of a lack of diversion of 
controlled substances more generally. However, it is important to 
note that these studies focused solely on buprenorphine, and it 
would be inappropriate to extrapolate their findings to all 
controlled substances given the unique characteristics of 
buprenorphine, particularly the combination buprenorphine product 
(Suboxone), which adds naloxone designed to deter diversion and 
misuse. Consistent with this data, buprenorphine has been provided 
unique treatment under this proposed NPRM and under the separate 
Expansion of Buprenorphine Treatment via Telemedicine Encounter 
final rule (RIN 1117-AB78). See, e.g., Tanz LJ, Jones CM, Davis NL, 
Compton WM, Baldwin GT, Han B, Volkow ND. Trends and Characteristics 
of Buprenorphine-Involved Overdose Deaths Prior to and During the 
COVID-19 Pandemic. JAMA Netw Open. 2023 Jan 3;6(1): e2251856. doi: 
10.1001/jamanetworkopen.2022.51856. PMID: 36662523; PMCID: 
PMC9860517; and Sade E. Johns, Mary Bowman, F. Gerard Moeller, 
Utilizing Buprenorphine in the Emergency Department after Overdose, 
Trends in Pharmacological Sciences, Volume 39, Issue 12, (2018), 
https://doi.org/10.1016/j.tips.2018.10.002 (Available: https://www.sciencedirect.com/science/article/pii/S0165614718301809.
---------------------------------------------------------------------------

    Given the dearth of comprehensive standardized data on diversion, 
DEA has had to rely on qualitative information and insights, such as 
anecdotal information, expert testimony from industry, and the 
specialized experience and knowledge of DEA's diversion investigators 
to identify emerging trends and inform enforcement strategies. Under 
the proposed NPRM, DEA would be implementing a system requiring 
pharmacies to inform DEA monthly about practitioner special 
registration prescriptions in accordance with proposed Sec.  1304.60, 
which will allow DEA to collect more uniform and comprehensive data in 
order to carry out more quantitative analyses to evaluate the diversion 
of controlled substances via telemedicine.

VIII. Summary of Economic Impact

    DEA estimates a cost savings to patients of $38.46 per first-time 
telemedicine visit that results in a controlled substance prescription. 
DEA estimates an annualized cost to practitioners, MLPs, and platforms 
of $1.61 for the labor cost of a registration application. DEA 
estimates a cost to practitioners and MLPs of $2.84 for annual 
reporting. DEA estimates a cost to practitioners and MLPs of $2.63 for 
PDMP checks. These unit costs were applied to the 10-year forecast of 
visits and registrations to develop a 10-year forecast of the cost 
savings, costs, and transfers. Furthermore, the annualized registration 
fees (transfers) were applied to the 10-year forecast of registrations 
to develop a 10-year forecast of transfers. The resulting cost savings, 
costs, and transfers for low, moderate (primary), and high estimates 
are shown in Table 37 below.

                                                    Table 37--Summary of Economic Impact ($ millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                   Year                         1          2          3          4          5          6          7          8          9          10
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Low Estimate
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patient cost savings......................       0.78       0.80       0.81       0.83       0.85       0.86       0.88       0.90       0.92       0.93
Costs.....................................       0.55       0.56       0.57       0.58       0.60       0.61       0.62       0.63       0.65       0.66
Net Cost Savings..........................       0.23       0.23       0.24       0.24       0.25       0.25       0.26       0.26       0.27       0.27

[[Page 6586]]

 
Transfers.................................       0.82       0.84       0.85       0.87       0.89       0.91       0.92       0.94       0.96       0.98
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Moderate (Primary) Estimate
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patient cost savings......................         18         19         20         21         22         23         25         26         27         28
Costs.....................................         13         14         14         15         16         16         17         18         19         20
Net Cost Savings..........................          5          6          6          6          7          7          7          8          8          8
Transfers.................................         19         20         21         22         23         25         26         27         28         30
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      High Estimate
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patient cost savings......................         51         60         72         86        102        121        144        172        204        243
Costs.....................................         36         43         51         60         72         85        102        121        144        171
Net Cost Savings..........................         15         18         21         25         30         36         42         51         60         72
Transfers.................................         53         63         76         90        107        127        151        180        215        255
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Figures are rounded as shown, Net Cost Savings may not add exactly in the table.

    DEA calculated the present value and annualized figures for the 
cost savings, costs and transfers shown in Table 37. The resulting 
present value and annualized figures are shown in Table 38 below.

                                       Table 38--Net Present Value and Annualized Cost Savings/Costs ($ millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                       High
                                                                Low          Moderate    ---------------------------------------------------------------
                                                                             (Primary)           h              PV*             A*              PV*
--------------------------------------------------------------------------------------------------------------------------------------------------------
Patient--Cost Savings...................................             7.7            0.85             205              23           1,097             122
Practitioner cost.......................................             5.4            0.60             145              16             774              86
NPV (Cost Savings)......................................             2.3            0.25              60               7             323              36
Registration fee (Transfers)............................             8.1            0.90             216              24           1,152             128
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Present value (PV) and annualized (A) values are based on a two percent (2%) discount rate.

    While DEA believes that the benefits of increased availability for 
treatment outweigh the dangers of a potential increase in diversion--so 
long as prescribers using the Special Registration for Telemedicine 
adhere to the safeguards inherent in the requirements of the proposed 
rule--the data system DEA is implementing will allow DEA to monitor the 
actual impact of the rule and be able to proactively make any necessary 
changes, either on the enforcement side or the regulatory side.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act (5 U.S.C. 601-612) (``RFA''), has reviewed this proposed rule and 
by approving it certifies that it will not have a significant economic 
impact on a substantial number of small entities.
    In accordance with the RFA, DEA evaluated the impact of this 
proposed rule on small entities. The proposed rule allows for DEA-
registered physicians and MLPs, or practitioners, to apply for three 
types of Special Registrations: the (1) Telemedicine Prescribing 
Registration authorizing qualified practitioners to prescribe Schedule 
III-V controlled substances via telemedicine; (2) the Advanced 
Telemedicine Prescribing Registration, authorizing qualified 
specialized 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.
    The proposed rule immediately requires practitioners to complete a 
PDMP check of (1) the state/territory where the patient is located; (2) 
the state/territory where the practitioner is located; and (3) any 
state/territory with PDMP reciprocity agreements with either the state/
territory where the patient is located or the state/territory where the 
practitioner is located. With a delayed effective date of three years, 
it requires a PDMP review of all 50 states and any U.S. districts and 
territories that maintain a PDMP prior to issuing a telemedicine 
prescription under the Special Registration.
    A significant number of physicians and MLPs work in offices and 
institutions that meet the RFA's definition of small entities. To 
estimate the number of affected entities, DEA first determined the 
North American Industry Classification System (``NAICS'') codes that 
most closely represent businesses that employ the potential applicants 
for the Special Registrations for Telemedicine. Then, DEA researched 
economic data for those codes. The source of the economic data is the 
Small Business Administration (``SBA''), Office of Advocacy, and is 
based on data provided by the U.S. Census Bureau, Statistics of U.S. 
Businesses (``SUSB'').\194\ The following business NAICS codes are 
estimated to represent businesses that employ the affected persons 
(potential applicants):
---------------------------------------------------------------------------

    \194\ SUSB's employer data contain the number of firms, number 
of establishments, employment, and annual payroll for employment 
size of firm categories by location and industry. A ``firm'' is 
defined as an aggregation of all establishments owned by a parent 
company (within a geographic location and/or industry) with some 
annual payroll.
---------------------------------------------------------------------------

     621111--Offices of Physicians, Except Mental Health 
Specialists
     621112--Offices of Physicians, Mental Health Specialists
     621420--Outpatient Mental Health and Substance Abuse 
Centers
     622210--Psychiatric and Substance Abuse Hospitals
    SUSB data contains the number of firms by size ranges for each of 
the NAICS codes. For the purposes of this analysis, the term ``firm'' 
as defined in the SUSB is used interchangeably with ``entity'' as 
defined in the RFA.
    To estimate the number of affected entities that are small 
entities, DEA compared the SUSB data for the number

[[Page 6587]]

of firms in various firm size ranges with SBA size standards for each 
of the representative NAICS codes. The SBA size standard is the firm 
size based on the number of employees or annual receipts depending on 
industry. The SBA size standards for NAICS codes 621111, 621112, 
621420, and 622210 are annual receipts of $16.0 million, $13.5 million, 
$19.0 million, and $47.0 million, respectively.\195\
---------------------------------------------------------------------------

    \195\ U.S. Small Business Administration, Table of size 
standards, Effective March 17, 2023, https://www.sba.gov/document/support-table-size-standards (https://www.sba.gov/sites/default/files/2023-06/Table%20of%20Size%20Standards_Effective%20March%2017%2C%202023_.xlsx)
 (Accessed October 18, 2024).
---------------------------------------------------------------------------

    The firms in each size range below the SBA size standard are small 
firms. The number of firms below the SBA size standard was added to 
determine the total number of small firms in each NAICS code. DEA 
estimates that a total of 175,503 entities are affected by this 
proposed rule, of which 172,436 (98.25 percent) are small entities. The 
analysis is summarized in Table 39 below.\196\
---------------------------------------------------------------------------

    \196\ SUSB, 2017 SUSB Annual Data Tables by Establishment 
Industry, U.S., Data by Enterprise Receipts Size, 6-digit NAICS, 
https://www.census.gov/data/tables/2017/econ/susb/2017-susb-annual.html (https://www2.census.gov/programs-surveys/susb/tables/2017/us_6digitnaics_rcptsize_2017.xlsx) (Accessed October 20, 2024).

                            Table 39--Number of Affected Entities and Small Entities
----------------------------------------------------------------------------------------------------------------
                                                                     Number of       SBA size        Number of
                           NAICS Code                                  firms       standard ($)     small firms
----------------------------------------------------------------------------------------------------------------
621111--Offices of Physicians, Except Mental Health Specialists.         161,286      16,000,000         157,563
621112--Offices of Physicians, Mental Health Specialists........          10,561      13,500,000          10,400
621420--Outpatient Mental Health and Substance Abuse Centers....           6,523      19,000,000           5,849
622210--Psychiatric and Substance Abuse Hospitals...............             396      47,000,000             200
    Total.......................................................         178,766  ..............         174,012
    Percent of Total............................................  ..............  ..............    97.3 percent
----------------------------------------------------------------------------------------------------------------

    The cost of the proposed rule impacts the affected entities and 
small entities on a ``per person'' basis. Rather than estimating the 
number of physicians and MLPs per firm, then the cost per firm, then 
whether the cost is significant, DEA employed a more direct approach 
based on the following logic:
     In order to continue as a financially stable entity, the 
affected firms must generate enough revenue to pay the wages of 
physicians and MLPs, and other operating expenses.
     Therefore, revenue for firms must be greater than the 
wages paid to practitioners.
     Therefore, if the cost of the proposed rule is not 
economically significant when compared to individual wages for 
practitioners, the cost of the proposed rule is not economically 
significant when compared to the annual revenue of the firms.
    In this analysis DEA has assumed a practitioner falls under the 
platform registration even though that registration is designed for 
telemedicine companies who are serving as intermediaries between 
patients and clinician practitioners, which is expected to exclude 
physician offices that have only one physician. If the cost is not 
burdensome for a single physician office, then it would not, 
presumably, be a burden for larger offices as well.
    As covered above, DEA estimates the cost to apply at $4.83 per 
application and that each registrant would apply for 2.5 individual 
Special Registrations (1 initial and 1.5 state) and 3.5 platform 
registrations (1 conventional, 1 initial telemedicine, and 1.5 state) 
for a total of 6 (2.5 + 3.5), at an annual rate of 2 Special 
Registrations per year (\6/3\), giving a total cost of $9.66 ($4.83 x 
2). This would also mean there would be fees of $888 for the platform 
conventional registration, $1,776 (888 x 2) for both the individual and 
platform initial Special Registration and $150 ($50 x 3) for 3 special 
state registrations, for a total of $2,814 ($888 + $1,776 + $150), or 
$938 per year ($2,814/3).
    DEA estimates the cost for reporting to DEA would be $2.84 per 
report. With one report per year, that would be an annual cost of 
$2.84. DEA estimates the cost per PDMP check for physicians, physician 
assistants, and nurse practitioners is $3.20, $1.54, and $1.50, 
respectively. DEA estimates the number of new PDMP checks per year by 
taking the total number of new PDMP checks and dividing by the number 
of Special Registrations. For the high estimate, the number of new PDMP 
checks per year is 83 (63,172,320/761,781). Being conservative, DEA 
used the year 10 figures. The total annual cost of the new PDMP checks 
per year is $266 (84 x $3.20), $128 (83 x $1.54), and $125 (83 x 1.50), 
respectively for physicians, physician assistants, and nurse 
practitioners.
    The average annual total economic impact for each registrant who 
prescribes under this proposed rule is then the combination of the PDMP 
check cost, registration time cost, reporting cost, and annualized 
registration fee. For physicians, physician assistants, and nurse 
practitioners, this is $1,210 ($266 + $3.22 + $2.84 + $938), $1,072 
($128 + $3.22 + $2.84 + $938), and $1,069 ($125 + $3.22 + $2.84 + 
$938), respectively.
    The average annual total economic impacts are compared to the 
loaded annual mean wages for physicians and MLPs (physician assistants 
and nurse practitioners). Based on the Bureau of Labor Statistics' 
(BLS) Occupational Employment and Wages data, DEA estimates an annual 
mean wage of $263,840 for physicians (occupation code 29-1210),\197\ 
$130,490 for physician assistants (occupation code 29-1071),\198\ and 
$128,490 for nurse practitioners (occupation code 29-1171).\199\ Based 
on the previously calculated load of 45.3 percent, the loaded annual 
mean wages are then $383,360 ($263,840 x 1.453), $189,602 ($130,490 x 
1.453), and $186,696 ($128,490 x 1.453), respectively.
---------------------------------------------------------------------------

    \197\ Bureau of Labor Statistics, Occupational Employment and 
Wages, May 2023 (29-1210 Physicians), annual mean wage, https://www.bls.gov/oes/2023/may/oes_nat.htm (Accessed 10/18/2024). While 
the weighted average of the 29-1210 Physicians and 29-1240 Surgeons 
is used to calculate costs earlier in the document, here, the total 
costs and fees is compared to the loaded median annual wages for 29-
1210 Physicians only. 29-1210 is the large majority and this 
analysis examines the impact on this occupation with the lower wage.
    \198\ Bureau of Labor Statistics, Occupational Employment and 
Wages, May 2023, 29-1071 Physician Assistants, median hourly wage 
https://www.bls.gov/oes/2023/may/oes_nat.htm. (Accessed 10/18/2024).
    \199\ Bureau of Labor Statistics, Occupational Employment and 
Wages, May 2023, 29-1171 Nurse Practitioners, annual mean wage, 
https://www.bls.gov/oes/2023/may/oes_nat.htm. (Accessed 10/18/2024).
---------------------------------------------------------------------------

    The total annual fees and costs are then 0.32 percent ($1,210/
$383,360),

[[Page 6588]]

0.57 percent ($1,072/$189,602), and 0.57 percent ($1,069/$186,696) of 
loaded annual wages for physicians, physician assistants, and nurse 
practitioners, respectively. Table 40 presents the details of the 
calculation.

                                                      Table 40--Costs and Fees as Percent of Wages
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                              Costs and
                                                                                               PDMP     Annualized     Total       Loaded      fees as
                                                                   Registration  Reporting    check    registration   cost and  annual mean   percent of
                                                                     cost ($)     cost ($)   cost ($)  fee cost ($)   fees ($)    wage ($)       wage
                                                                                                                                              (percent)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physicians.......................................................         3.22        2.84        266          938       1,210      383,360         0.32
Physician Assistants.............................................         3.22        2.84        128          938       1,072      189,602         0.57
Nurse Practitioners..............................................         3.22        2.84        125          938       1,069      186,696         0.57
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The economic impact of applying for the Special Registration for 
Telemedicine represents a small fraction (0.32 percent, 0.57 percent, 
and 0.57 percent) of annual wages. DEA estimates the proposed rule will 
not have a significant economic impact on individual physicians and 
MLPs. The small entities that employ the potentially affected 
physicians and MLPs are expected to generate enough revenue to pay 
their wages. Therefore, DEA concludes the proposed rule will not have a 
significant economic impact on a substantial number of small entities.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    DEA has determined that this proposed rule may have Tribal 
implications, as defined by Executive Order 13175. The determination 
that this proposed rule will have Tribal implications is, in part, 
based off the several public comments made by Tribal organizations on 
the 2023 General Telemedicine NPRM and the Buprenorphine NPRM, stating 
that the requirements in those two proposed rules would have a 
substantial impact on Tribal communities. The most prominent concerns 
of the Tribal organizations involved the extreme remoteness and 
practitioner shortages faced by some Tribal communities. Specifically, 
as a result of these obstacles to care, the Tribal communities noted 
the challenges posed by, as proposed in the 2023 NPRMs, necessitating 
an in-person medical examination to obtain prescriptions for certain 
substances, as well as the 30-day telemedicine prescription supply 
limit. On June 13 and 27, 2024, OTJ and DEA hosted two Tribal 
consultations to have broad discussions regarding the practice of 
telemedicine with Tribal communities. Many of the Tribal organizations 
that participated in the two Tribal consultations reiterated their 
concerns about any telemedicine rule that would require an in-person 
medical examination to obtain prescriptions for certain substances and 
a 30-day telemedicine prescription supply limit.
    After carefully considering the information and insights shared in 
the public comments to the two 2023 NPRMs, during the Telemedicine 
Listening Sessions, and during the June 2024 Tribal Consultations, DEA 
reevaluated its approach and determined that the best course of action 
was to proceed with the promulgation of a Special Registration rule. 
Notably, this proposed Special Registration rule no longer contains an 
in-person medical examination requirement for certain substances and no 
longer contains a 30-day telemedicine prescription supply limit 
requirement; DEA believes these changes have largely addressed the 
prominent concerns raised by Tribes. DEA encourages Tribal members and 
entities to submit public comments on this Special Registration NPRM. 
Furthermore, it intends to continue Tribal consultations on 
Telemedicine, including the proposed requirements of the Special 
Registration NPRM, to ensure meaningful collaboration with Tribal 
governments impacted by DEA's telemedicine policies.

Paperwork Reduction Act of 1995

    This proposed rule would impose new collections and modify existing 
collections of information under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501-3521. DEA has identified the following collection(s) of 
information related to this proposed rule. An agency may not conduct or 
sponsor, and a person is not required to respond to a collection of 
information unless it displays a valid OMB control number. Copies of 
existing information collections approved by OMB may be obtained at 
http://www.reginfo.gov/public/do/PRAMain.

A. Collections of Information Associated With the Proposed Rule

1. Title: Application for Registration, Registration Renewal, Special 
Registration for Telemedicine, and Changes and Modifications to Special 
Registration for Telemedicine, Forms DEA-224/224A/224S/224S-M
OMB Control Number: 1117-0014
Form Number: DEA-224/DEA-224A/DEA-224S/224S-M

    DEA is proposing to amend its regulations by creating two new forms 
for all Special Registration applicants to use when applying for or 
modifying a Special Registration for Telemedicine and a State 
Telemedicine Registration. DEA Form 224S (Application for Special 
Registration for Telemedicine Under the Controlled Substances Act) will 
allow Special Registration applicants to use one form to apply for the 
Telemedicine Prescribing Registration (CS III-V), the Advanced 
Telemedicine Prescribing Registration (CS II-V), the Telemedicine 
Platform Registration (CS II-V), and the State Telemedicine 
Registration for each state in which a patient will be located. Special 
Registration applicants will be required to provide one Special 
Registered Location. Platform practitioners will be required to 
disclose all employment, contractual relationships, or professional 
affiliations with any clinician special registrant and Online Pharmacy 
and their respective registration numbers. Clinician practitioners will 
be required to disclose all employment, contractual relationships, and 
professional affiliations, including with any covered online 
telemedicine platforms and the respective covered online telemedicine 
platform's Telemedicine Platform Special Registration number; their 
practice specialties; and attest to their ability and intention to 
check relevant state PDMPs prior to issuing a special registration 
prescription. All Special Registration applicants will also be required 
to attest to having devised, and committing to maintain, anti-diversion

[[Page 6589]]

policies and procedures and to the facts and circumstances that form 
the basis for their legitimate need for a Special Registration for 
Telemedicine. Additionally, those practitioners that are exempt from 
obtaining State Telemedicine Registrations will be required to identify 
all states in which patients will be located when being treated via 
telemedicine.
    DEA Form 224S-M (Application for Changes and Modifications to 
Special Registration) provides special registrants with a means to 
comply with the proposed requirement of notifying DEA, within 14 
business days, of any changes to the information provided in the 
Special Registration application (Form 224S); such changes include if a 
clinician special registrant becomes employed by, contracts with, or 
otherwise becomes professionally affiliated with a new DTC online 
telemedicine platform not previously disclosed on the original Form 
224S or if any clinician special registrant or platform special 
registrant needs to make modifications to their Special Registration. 
The information submitted on these two forms will enhance transparency, 
patient safety, and anti-diversion efforts.
    The below estimates are based on the ``moderate (primary)'' 
estimates made in the E.O. 12866 section above. DEA estimates the 
following number of respondents and burden associated with this 
collection of information:

 Number of respondents: 670,916
 Frequency of response: 1 per year
 Number of responses: 718,917
 Burden per response: 0.20 hours (calculated)
 Total annual hour burden: 144,200 hours
2. Title: Special Registration Recordkeeping and Prescribing 
Requirements
OMB Control Number: 1117-New
Form Number: N/A

    Clinician special registrants will remain subject to existing 
recordkeeping and prescribing requirements. However, under this rule, 
DEA is proposing additional requirements under the Special Registration 
framework.
    Clinician special registrants would be required to maintain all 
records arising from telemedicine encounters under the Special 
Registration framework at the special registered location for a minimum 
of two (2) years. The clinician special registrant will be required to 
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. This proposed requirement enhances public 
safety by making detection of diversion patterns and illegitimate 
prescribing practices easier to spot during DEA investigations. It will 
also alleviate the practical burden for special registrants by 
centralizing recordkeeping at the special registered location rather 
than requiring special registrants to maintain records in every state 
where telemedicine patients are located. Additionally, this proposed 
rule will require, in addition to the requirements of a prescription 
found in 21 CFR 1306.05(a), two additional elements for special 
registration prescriptions to include: (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 number of the clinician practitioner and, if 
a platform practitioner facilitated the prescription, the platform 
practitioner. If a clinician special registrant is exempt from 
obtaining a State Telemedicine Registration, the clinician special 
registrant will be required to instead provide a notation on the 
prescription identifying the state in which the patient is located. 
This information will provide the pharmacist with the necessary 
information to determine whether the clinician practitioner has the 
authority to prescribe, and the platform practitioner has the authority 
to dispense, Schedule II controlled substances, and provide the 
pharmacist with the information necessary to verify that special 
registration prescriptions are prescribed and dispensed by special 
registrants authorized within the appropriate state.
    This proposed rule requires that clinician special registrants, or 
a delegated employee or contractor under the direct supervision of the 
clinician special registrant, verify the identity of patients seeking 
treatment via telemedicine by requiring that the patient present a 
state or federal government-issued photo identification card or 
acceptable alternative forms of identification through the camera of 
the audio-video telecommunications system. The clinician special 
registrant will be required to photograph the patient presenting their 
photo identification card or other acceptable documents during an 
initial telemedicine encounter or accept a copy of such identification 
card or document and will be required to maintain this photographic 
record for a minimum of two (2) years. The photographic records, or 
copies of such, will be securely stored in the patient's medical record 
or chart to ensure patient privacy. This requirement ensures that 
patients' identities are verified, and the photographic record 
establishes a clear link between the patient's identity and the special 
registration prescription.
    Platform special registrants will be required to maintain certain 
clinician special registrant records insomuch as that platform special 
registrant has a covered platform relationship with the clinician 
special registrant. Such records include documents related to 
verification of the clinical special registrant's credentials; 
employment contracts and any other contract between the platform 
special registrant and clinician special registrant; and any 
disciplinary actions or sanctions, or documentation of complaints, 
disputes, or incidents involving the practice of telemedicine. The 
platform special registrant will be required to maintain and update the 
credential verification and conduct-related records for a minimum of 
two (2) years. This requirement will help to address any potential 
issues of diversion, misconduct, or inadequate screening procedures and 
provides additional regulatory oversight over remote prescribing.
    This proposed rule will require, in addition to the requirements of 
a prescription found in 21 CFR 1306.05(a), two additional elements for 
special registration prescriptions to include: (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 number of the clinician 
practitioner and, if a platform practitioner facilitated the 
prescription, the platform practitioner. If a clinician special 
registrant is exempt from obtaining a State Telemedicine Registration, 
the clinician special registrant will be required to instead provide a 
notation on the prescription identifying the state in which the patient 
is located. This information will provide the pharmacist with the 
necessary information to determine whether the clinician practitioner 
has the authority to prescribe, and the platform practitioner has the 
authority to dispense, Schedule II controlled substances, and provide 
the pharmacist with the information necessary to verify that special 
registration prescriptions are prescribed and dispensed by special 
registrants authorized within the appropriate state.
    The below estimates are based on the ``moderate (primary)'' 
estimates made in the E.O. 12866 section above. DEA estimates the 
following number of

[[Page 6590]]

respondents and burden associated with this collection of information:

 Number of respondents: 57,552
 Frequency of response: 174.26562 (as needed, calculated)
 Number of responses: 10,029,335
 Burden per response: 0.0008602 (calculated)
 Total annual hour burden: 8,627 hours
3. Title: Special Registration Reporting Requirements
OMB Control Number: 1117-New
Form Number: N/A

    This proposed rule will require both individual special registrants 
and platform special registrants to electronically report to DEA under 
21 CFR 1304.61, on an annual basis, the total number of new patients in 
each state where at least one special registration prescription for a 
Schedule II controlled substance and certain Schedule III-V controlled 
substances, including Ketamine, Tramadol, and any depressant 
constituting a benzodiazepine, has been issued; 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 depressants constituting a benzodiazepines, which 
were issued by the special registrant, in aggregate and across all 
states. Amid the ongoing opioid epidemic, this vital information will 
provide DEA with accurate and up to date data on the prescribing of 
controlled substances via telemedicine.
    This proposed rule will also require pharmacies to electronically 
report, within the first seven (7) days of the start of every month, 
aggregate data 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 depressant constituting a benzodiazepine. For each of 
these controlled substances, the pharmacy will be required to report 
the number of prescriptions filled, the volume of the controlled 
substance dispensed, and the number of patients prescribed the 
controlled substance. These requirements provide valuable oversight of 
telemedicine prescriptions under the Special Registration, enable the 
detection of irregularities or suspicious prescribing and dispensing 
practices, and will help DEA understand any shifts in demand for 
medications via telemedicine.
    The below estimates are based on the ``moderate (primary)'' 
estimates made in the E.O. 12866 section above. DEA estimates the 
following number of respondents and burden associated with this 
collection of information:

     Number of respondents: 69,134
     Frequency of response: 6.950774 (calculated)
     Number of responses: 871,488
     Burden per response: 0.006863 hours (calculated)
     Total annual hour burden: 5,981 hours

B. Request for Comments Regarding the Proposed Collections of 
Information

    Written comments and suggestions from the public and affected 
entities concerning the proposed collections of information are 
encouraged. Under the PRA, DEA is required to provide a notice 
regarding the proposed collections of information in the Federal 
Register with the notice of proposed rulemaking and solicit public 
comment. Pursuant to section 3506(c)(2) of the PRA (44 U.S.C. 
3506(c)(2)), DEA solicits comment on the following issues:
     Whether the proposed collection of information is 
necessary for the proper performance of the functions of DEA, including 
whether the information will have practical utility.
     The accuracy of DEA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used.
     Recommendations to enhance the quality, utility, and 
clarity of the information to be collected.
     Recommendations to minimize the burden of the collection 
of information on those who are to respond, including through the use 
of automated collection techniques or other forms of information 
technology.
    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 comments refer to RIN 
1117-AB40/Docket No. DEA-407. All comments must be submitted to OMB on 
or before March 18, 2025. [``The final rule will respond to any OMB or 
public comments on the information collection requirements contained in 
this proposed rule.'']
    If you need a copy of the proposed information collection 
instrument(s) with instructions or additional information, please 
contact the Regulatory Drafting and Policy Support Section (DPW), 
Diversion Control Division, Drug Enforcement Administration; Mailing 
Address: 8701 Morrissette Drive, Springfield, Virginia 22152; 
Telephone: (571) 776-3882.

Unfunded Mandates Reform Act of 1995

    The estimated annual impact of this proposed rule is minimal. Thus, 
DEA has determined in accordance with the Unfunded Mandates Reform Act 
of 1995 (UMRA) (2 U.S.C. 1501 et seq.) that this action would not 
result in any federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted for inflation) in any 
one year. Therefore, neither a Small Government Agency Plan nor any 
other action is required under provisions of UMRA.

List of Subjects

21 CFR Part 1300

    Chemicals, Drug traffic control.

21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Prescription
    drugs, Security measures.

21 CFR Part 1304

    Drug traffic control, Reporting and recordkeeping requirements.

21 CFR Part 1306

    Administrative practice and procedure, Drug traffic control, 
Prescription drugs, Reporting and recordkeeping requirements.

    For the reasons set out above, the Drug Enforcement Administration 
proposes to amend 21 CFR parts 1300, 1301, 1304, and 1306 as follows:

PART 1300--DEFINITIONS

0
1. Revise the authority citation for part 1300 to read as follows:

    Authority: 21 U.S.C. 802, 821, 822, 829, 831(h), 871(b), 951, 
958(f).

0
2. In Sec.  1300.01(b) the add the term ``Clinician practitioner'' and 
revise the term ``Institutional practitioner'' shall be revised, as 
follows:


Sec.  1300.01  Definitions related to controlled substances

* * * * *
    Clinician practitioner is an individual practitioner who provides 
direct patient care or assesses, diagnoses, or treats medical 
conditions.
* * * * *
    Institutional practitioner means a hospital or other person (other 
than an individual) licensed, registered, or otherwise permitted, by 
the United States or the jurisdiction in which it

[[Page 6591]]

practices, to dispense a controlled substance in the course of 
professional practice, but does not include a pharmacy or covered 
online telemedicine platform.
* * * * *
0
3. Revise and republish Sec.  1300.04 to read as follows:


Sec.  1300.04  Definitions relating to the dispensing of controlled 
substances by means of the internet.

    Any term not defined in this part or elsewhere in this chapter 
shall have the definition set forth in sections 102 and 309 of the Act 
(21 U.S.C. 802, 829).
    Advanced Telemedicine Prescribing Registration means a type of 
Special Registration for Telemedicine in which the registered 
practitioner is authorized to prescribe Schedules II through V 
controlled substances through the practice of telemedicine under 21 
U.S.C. 802(54)(E).
    Audio-video telecommunications system means the multimedia 
communications equipment that includes, at a minimum, audio and video 
equipment permitting two-way, real-time interactive communication 
between the patient and practitioner, mid-level practitioner, or 
pharmacist.
    Clinician special registrant means a special registrant issued 
either the Telemedicine Prescribing Registration or the Advanced 
Telemedicine Prescribing Registration under 1301.11(c)(2) and (3) of 
this chapter, respectively.
    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.
    Covered platform relationship means the formal association between 
a covered online telemedicine platform and a 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 individual practitioner, 
via an audio-video telecommunications system, for the diagnosis of 
patients and the treatment of those patients via prescription of 
controlled substances.
    Covering practitioner means, with respect to a patient, a 
practitioner who conducts a medical evaluation (other than an in-person 
medical evaluation) at the request of a practitioner who:
    (1) Has conducted at least one in-person medical evaluation of the 
patient or an evaluation of the patient through the practice of 
telemedicine, within the previous 24 months; and
    (2) Is temporarily unavailable to conduct the evaluation of the 
patient.
    Deliver, distribute, or dispense by means of the internet refers, 
respectively, to any delivery, distribution, or dispensing of a 
controlled substance that is caused or facilitated by means of the 
internet.
    Filling new prescriptions for controlled substances in Schedule 
III, IV, or V means filling a prescription for an individual for a 
controlled substance in Schedule III, IV, or V, if:
    (1) The pharmacy dispensing that prescription has previously 
dispensed to the patient a controlled substance other than by means of 
the internet and pursuant to the valid prescription of a practitioner 
that meets the applicable requirements of subsections (b) and (c) of 
section 309 of the Act (21 U.S.C. 829) and Sec. Sec.  1306.21 and 
1306.22 of this chapter (for purposes of this definition, such a 
prescription shall be referred to as the ``original prescription'');
    (2) The pharmacy contacts the practitioner who issued the original 
prescription at the request of that individual to determine whether the 
practitioner will authorize the issuance of a new prescription for that 
individual for the controlled substance described in paragraph (d)(1) 
of this section (i.e., the same controlled substance as described in 
paragraph (d)(1)); and
    (3) The practitioner, acting in the usual course of professional 
practice, determines there is a legitimate medical purpose for the 
issuance of the new prescription.
    Homepage means the opening or main page or screen of the website of 
an online pharmacy that is viewable on the internet.
    Hospice care means a set of special services that are provided to 
individuals who are terminally ill. The focus is on comfort, not on 
curing an illness. Hospice programs can be delivered in a person's home 
or in a hospice center.
    In-person medical evaluation means a medical evaluation that is 
conducted with the patient in the physical presence of the 
practitioner, without regard to whether portions of the evaluation are 
conducted by other health professionals. Nothing in this paragraph 
shall be construed to imply that one in-person medical evaluation 
demonstrates that a prescription has been issued for a legitimate 
medical purpose within the usual course of professional practice.
    Internet means collectively the myriad of computer and 
telecommunications facilities, including equipment and operating 
software, which comprise the interconnected worldwide network of 
networks that employ the Transmission Control Protocol/internet 
Protocol, or any predecessor or successor protocol to such protocol, to 
communicate information of all kinds by wire or radio.
    Local in-person medical practice means 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.
    Online pharmacy means a person, entity, or internet site, whether 
in the United States or abroad, that knowingly or intentionally 
delivers, distributes, or dispenses, or offers or attempts to deliver, 
distribute, or dispense, a controlled substance by means of the 
internet. The term includes, but is not limited to, a pharmacy that has 
obtained a modification of its registration pursuant to Sec. Sec.  
1301.13 and 1301.19 of this chapter that currently authorizes it to 
dispense controlled substances by means of the internet, regardless of 
whether the pharmacy is currently dispensing controlled substances by

[[Page 6592]]

means of the internet. The term does not include:
    (1) Manufacturers or distributors registered under subsection (a), 
(b), (d), or (e) of section 303 of the Act (21 U.S.C. 823(a), (b), (d), 
or (e)) (Sec.  1301.13 of this chapter) who do not dispense controlled 
substances to an unregistered individual or entity;
    (2) Nonpharmacy practitioners who are registered under section 
303(f) of the Act (21 U.S.C. 823(f)) (Sec.  1301.13 of this chapter) 
and whose activities are authorized by that registration;
    (3) Any hospital or other medical facility that is operated by an 
agency of the United States (including the Armed Forces), provided such 
hospital or other facility is registered under section 303(f) of the 
Act (21 U.S.C. 823(f)) (Sec.  1301.13 of this chapter);
    (4) A health care facility owned or operated by an Indian tribe or 
tribal organization, only to the extent such facility is carrying out a 
contract or compact under the Indian Self-Determination and Education 
Assistance Act;
    (5) Any agent or employee of any hospital or facility referred to 
in paragraph (h)(3) or (h)(4) of this section, provided such agent or 
employee is lawfully acting in the usual course of business or 
employment, and within the scope of the official duties of such agent 
or employee, with such hospital or facility, and, with respect to 
agents or employees of health care facilities specified in paragraph 
(h)(4) of this section, only to the extent such individuals are 
furnishing services pursuant to the contracts or compacts described in 
such paragraph;
    (6) Mere advertisements that do not attempt to facilitate an actual 
transaction involving a controlled substance;
    (7) A person, entity, or internet site that is not in the United 
States and does not facilitate the delivery, distribution, or 
dispensing of a controlled substance by means of the internet to any 
person in the United States;
    (8) A pharmacy registered under section 303(f) of the Act (21 
U.S.C. 823(f)) (Sec.  1301.13 of this chapter) whose dispensing of 
controlled substances via the internet consists solely of:
    (i) Refilling prescriptions for controlled substances in Schedule 
III, IV, or V, as defined in paragraph (k) of this section; or
    (ii) Filling new prescriptions for controlled substances in 
Schedule III, IV, or V, as defined in paragraph (d) of this section;
    (9)(i) Any registered pharmacy whose delivery, distribution, or 
dispensing of controlled substances by means of the internet consists 
solely of filling prescriptions that were electronically prescribed in 
a manner authorized by this chapter and otherwise in compliance with 
the Act.
    (ii) A registered pharmacy will be deemed to meet this exception 
if, in view of all of its activities other than those referred to in 
paragraph (h)(9)(i) of this section, it would fall outside the 
definition of an online pharmacy;
    (10)(i) Any registered pharmacy whose delivery, distribution, or 
dispensing of controlled substances by means of the internet consists 
solely of the transmission of prescription information between a 
pharmacy and an automated dispensing system located in a long term care 
facility when the registration of the automated dispensing system is 
held by that pharmacy as described in Sec. Sec.  1301.17 and 1301.27 
and the pharmacy is otherwise complying with this chapter.
    (ii) A registered pharmacy will be deemed to meet this exception 
if, in view of all of its activities other than those referred to in 
paragraph (h)(10)(i) of this section, it would fall outside the 
definition of an online pharmacy; or
    (11) A covered online telemedicine platform as defined in this 
section.
    Palliative care means patient and family-centered care that 
optimizes quality of life by anticipating, preventing, and treating 
suffering. Palliative care throughout the continuum of illness involves 
addressing physical, intellectual, emotional, social, and spiritual 
needs and to facilitate patient autonomy, access to information, and 
choice.
    Platform practitioner means a covered online telemedicine platform 
that dispenses controlled substances by virtue of its central 
involvement as an intermediary in the remote prescribing of controlled 
substances by an individual practitioner. Platform practitioners are 
subject to the requirements imposed upon non-pharmacist practitioners 
under the Controlled Substances Act, 21 U.S.C. 801-904, and its 
regulations.
    Platform special registrant means a special registrant issued the 
Telemedicine Platform Registration under 1301.11(c)(4) of this chapter.
    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 defined in 
42 CFR 410.78(a)(3), which practice falls within a category listed in 
paragraphs (1) through (7) of this definition:
    (1) Treatment in a hospital or clinic. The practice of telemedicine 
is being conducted while the patient is being treated by, and 
physically located in, a hospital or clinic registered under section 
303(f) of the Act (21 U.S.C. 823(f)) by a practitioner acting in the 
usual course of professional practice, who is acting in accordance with 
applicable State law, and who is registered under section 303(f) of the 
Act (21 U.S.C. 823(f)) in the State in which the patient is located, 
unless the practitioner:
    (i) Is exempted from such registration in all States under section 
302(d) of the Act (21 U.S.C. 822(d); or
    (ii) Is an employee or contractor of the Department of Veterans 
Affairs who is acting in the scope of such employment or contract, and 
registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any 
State or is utilizing the registration of a hospital or clinic operated 
by the Department of Veterans Affairs registered under section 303(f);
    (2) Treatment in the physical presence of a practitioner. The 
practice of telemedicine is being conducted while the patient is being 
treated by, and in the physical presence of, a practitioner acting in 
the usual course of professional practice, who is acting in accordance 
with applicable State law, and who is registered under section 303(f) 
of the Act (21 U.S.C. 823(f)) in the State in which the patient is 
located, unless the practitioner:
    (i) Is exempted from such registration in all States under section 
302(d) of the Act (21 U.S.C. 822(d)); or
    (ii) Is an employee or contractor of the Department of Veterans 
Affairs who is acting in the scope of such employment or contract, and 
registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any 
State or is using the registration of a hospital or clinic operated by 
the Department of Veterans Affairs registered under section 303(f);
    (3) Indian Health Service or Tribal organization. The practice of 
telemedicine is being conducted by a practitioner who is an employee or 
contractor of the Indian Health Service, or is working for an Indian 
Tribe or Tribal organization under its contract or compact with the 
Indian Health Service under the Indian Self-Determination and Education 
Assistance Act; who is acting within the scope of the employment, 
contract, or compact; and who is designated as an internet Eligible 
Controlled Substances Provider by the Secretary of Health and Human 
Services under section 311(g)(2) of the Act (21 U.S.C. 831(g)(2));

[[Page 6593]]

    (4) Public health emergency declared by the Secretary of Health and 
Human Services. The practice of telemedicine is being conducted during 
a public health emergency declared by the Secretary of Health and Human 
Services under section 319 of the Public Health Service Act (42 U.S.C. 
247d), and involves patients located in such areas, and such controlled 
substances, as the Secretary of Health and Human Services, with the 
concurrence of the Administrator, designates, provided that such 
designation shall not be subject to the procedures prescribed by the 
Administrative Procedure Act (5 U.S.C. 551-559 and 701-706);
    (5) Special registration. The practice of telemedicine is being 
conducted by a practitioner who has obtained from the Administrator a 
special registration under section 311(h) of the Act (21 U.S.C. 
831(h));
    (6) Department of Veterans Affairs medical emergency. The practice 
of telemedicine is being conducted:
    (i) In a medical emergency situation:
    (A) That prevents the patient from being in the physical presence 
of a practitioner registered under section 303(f) of the Act (21 U.S.C. 
823(f)) who is an employee or contractor of the Veterans Health 
Administration acting in the usual course of business and employment 
and within the scope of the official duties or contract of that 
employee or contractor;
    (B) That prevents the patient from being physically present at a 
hospital or clinic operated by the Department of Veterans Affairs 
registered under section 303(f) of the Act (21 U.S.C. 823(f));
    (C) During which the primary care practitioner of the patient or a 
practitioner otherwise practicing telemedicine within the meaning of 
this paragraph is unable to provide care or consultation; and
    (D) That requires immediate intervention by a health care 
practitioner using controlled substances to prevent what the 
practitioner reasonably believes in good faith will be imminent and 
serious clinical consequences, such as further injury or death; and
    (ii) By a practitioner that:
    (A) Is an employee or contractor of the Veterans Health 
Administration acting within the scope of that employment or contract;
    (B) Is registered under section 303(f) of the Act (21 U.S.C. 
823(f)) in any State or is utilizing the registration of a hospital or 
clinic operated by the Department of Veterans Affairs registered under 
section 303(f); and
    (C) Issues a controlled substance prescription in this emergency 
context that is limited to a maximum of a five-day supply which may not 
be extended or refilled; or
    (7) Other circumstances specified by regulation. The practice of 
telemedicine is being conducted under any other circumstances that the 
Administrator and the Secretary of Health and Human Services have 
jointly, by regulation, determined to be consistent with effective 
controls against diversion and otherwise consistent with the public 
health and safety.
    Refilling prescriptions for controlled substances in Schedule III, 
IV, or V: (1) Means the dispensing of a controlled substance in 
Schedule III, IV, or V in accordance with refill instructions issued by 
a practitioner as part of a valid prescription that meets the 
requirements of subsections (b) and (c) of section 309 of the Act (21 
U.S.C. 829) and Sec. Sec.  1306.21 and 1306.22 of this chapter, as 
appropriate; and
    (2) Does not include the issuance of a new prescription to an 
individual for a controlled substance that individual was previously 
prescribed.
    Special registered location means the physical address of record 
for a Special Registration for Telemedicine. The special registered 
location shall be the same address as one of the special registrant's 
1301.13(e)(1)(iv) registered locations, unless exempted by Sec.  
1301.13(k)(1) of this chapter, in which case the special registered 
location shall be the physical address provided on the special 
registrant's Form 224S.
    Special registrant means a practitioner who has been issued a 
Special Registration for Telemedicine (either a Telemedicine 
Prescribing Registration, an Advanced Telemedicine Prescribing 
Registration, or a Telemedicine Platform Registration).
    Special Registration for Telemedicine means a registration issued 
by the Administrator pursuant to section 311(h) of the Act (21 U.S.C. 
831(h)) to a practitioner who seeks to engage in the practice of 
telemedicine pursuant to section 102(54)(E) of the Act (21 U.S.C. 
802(54)(E)) and 1300.04 of this chapter, which may be used to prescribe 
controlled substances by means of the internet (within the meaning of 
section 102(51) of the Act (21 U.S.C. 802(51)) without having first 
conducted an in-person medical evaluation with patients to whom such 
prescriptions are being issued. The three types of Special Registration 
for Telemedicine are the Telemedicine Prescribing Registration, the 
Advanced Telemedicine Prescribing Registration, and the Telemedicine 
Platform Registration.
    Special registration prescription means a prescription, defined 
under Sec.  1300.01 of this chapter, 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 this section. A special registration prescription is 
facilitated if:
    (1) The prescription is issued to a patient who was introduced to 
the prescribing practitioner through a covered platform relationship; 
or
    (2) A covered online telemedicine platform facilitated the 
telemedicine encounter that resulted in the prescription, including by 
providing audio-visual communication services.
    State Telemedicine Registration means a limited type of 21 U.S.C. 
823(g) registration authorizing an individual special registrant to 
prescribe special registration prescriptions to patients located within 
the state or a platform special registrant to dispense Schedule II-V 
controlled substances to patients located within the state, as required 
by section 311(h)(1)(B) of the Act (21 U.S.C. 831(h)(1)(B)).
    Telemedicine Platform Registration means a type of Special 
Registration for Telemedicine in which the registered covered online 
telemedicine platform is authorized to dispense Schedules II through V 
controlled substances through the practice of telemedicine under 21 
U.S.C. 802(54)(E).
    Telemedicine Prescribing Registration means a type of Special 
Registration for Telemedicine in which the registered practitioner is 
authorized to prescribe Schedules III through V controlled substances 
through the practice of telemedicine under 21 U.S.C. 802(54)(E).
    Valid prescription means a prescription that is issued for a 
legitimate medical purpose in the usual course of professional practice 
by:
    (1) A practitioner who has conducted at least one in-person medical 
evaluation of the patient; or
    (2) A covering practitioner.
    (3) The definition of valid prescription shall not be construed to 
imply that one in-person medical evaluation demonstrates that a 
prescription has been issued for a legitimate medical purpose within 
the usual course of professional practice.

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
4. The authority citation for part 1301 continues to read as follows:


[[Page 6594]]


    Authority:  21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.

0
5. In Sec.  1301.11, revise the section heading and add paragraphs (c) 
and (d) to read as follows:


Sec.  1301.11  Persons required to register; requirement of 
modification of registration authorizing activity as an online 
pharmacy; Eligibility Requirements for Special Registration for 
Telemedicine; State Telemedicine Registrations.

* * * * *
    (c) Eligibility for Special Registration for Telemedicine. 
Clinician practitioners and covered online telemedicine platforms are 
eligible for the Special Registration for Telemedicine under Sec.  
1300.04 of this chapter. Clinician practitioners are eligible for 
either the Telemedicine Prescribing Registration or Advanced 
Telemedicine Prescribing Registration, and platform practitioners are 
eligible for the Telemedicine Platform Registration pursuant to 21 
U.S.C. 802(54)(E) and 21 U.S.C. 831(h) subject to the following:
    (1) In general. (i) A clinician practitioner applicant or a covered 
online telemedicine platform applicant shall be required to hold one or 
more registrations under Sec.  1301.13(e)(1)(iv) of this chapter in a 
state in which they are licensed, registered, or otherwise permitted to 
prescribe or dispense controlled substances through telemedicine. 
Clinician practitioners exempted from obtaining a State Telemedicine 
Registration for every state in which patients to whom they will issue 
special registration prescriptions are located under Sec.  1301.11(d) 
of this chapter are exempted from this requirement.
    (ii) Notwithstanding Sec.  1301.23(a) of this chapter, all 
clinician practitioners must apply for and obtain a Telemedicine 
Prescribing Registration or Advanced Telemedicine Prescribing 
Registration before issuing special registration prescriptions.
    (2) Telemedicine Prescribing Registration (Schedules III-V). If the 
condition required in paragraph (c)(1) of this section is satisfied, a 
Practitioner or Mid-Level Practitioner, as defined under Sec.  
1300.01(b) of this chapter, may have a legitimate need under 21 U.S.C. 
831(h) for the Telemedicine Prescribing Registration and may apply for 
the registration to prescribe Schedules III-V controlled substances 
when they anticipate that they will be treating patients for whom 
requiring in-person medical evaluations could impose significant 
burdens on the patients to maintain a bona fide practitioner-patient 
relationships.
    (3) Advanced Telemedicine Prescribing Registration (Schedules II-
V). If the condition required in paragraph (c)(1) of this section is 
satisfied, a Practitioner or Mid-Level Practitioner may have a 
legitimate need under 21 U.S.C. 831(h) for the Advanced Telemedicine 
Prescribing Registration, and may apply for the registration to 
prescribe Schedules II-V controlled substances, when they anticipate 
that they will be treating patients for whom requiring in-person 
medical evaluations could impose significant burdens on the patient to 
maintain bona fide practitioner-patient relationships, and the 
practitioner or Mid-Level Practitioner is one or more of the following:
    (i) The practitioner is a psychiatrist or is board certified in the 
treatment of psychiatric or psychological disorders;
    (ii) The practitioner is a hospice care physician or is board 
certified in hospice care;
    (iii) The practitioner is a palliative care physician or is board 
certified in palliative care;
    (iv) The practitioner renders treatment at one or more long term 
care facilities;
    (v) The practitioner is a pediatrician or is board certified in 
pediatric care; and/or
    (vi) The practitioner is a neurologist or is board certified in the 
treatment of neurological disorders unrelated to the treatment and 
management of pain.
    (4) Telemedicine Platform Registration (Schedules II-V). A covered 
online telemedicine platform, as defined under Sec.  1300.04 of this 
chapter, may have a legitimate need under 21 U.S.C. 831(h) for the 
Telemedicine Platform Registration, and shall apply for the 
registration to dispense Schedules II-V controlled substances, when the 
covered online telemedicine platform:
    (i) Anticipates being compensated for introducing or facilitating 
connections between patients seeking remote medical consultations and 
practitioners, via an audio-video telecommunications system, for the 
diagnosis of patients and the treatment of those patients via 
prescription of controlled substances;
    (ii) Is compliant with federal and state regulations;
    (iii) Provides oversight over clinician practitioners' prescribing 
practices; and
    (iv) Takes measures to prioritize patient safety and prevent 
diversion, abuse, or misuse of controlled substances.
    (d) State Telemedicine Registrations. Practitioners issued any of 
the three types of Special Registration for Telemedicine shall obtain a 
State Telemedicine Registration defined under Sec.  1300.04 of this 
chapter, for every state in which patients to whom special registration 
prescriptions will be issued are located. As a limited type of 21 
U.S.C. 823(g) registration, the Administrator shall issue the State 
Telemedicine Registration when it is consistent with the public 
interest pursuant 21 U.S.C. 823(g)(1). The following clinician 
practitioners are exempted from obtaining a State Telemedicine 
Registration for every state:
    (1) Officials of the U.S. Army, Navy, Marine Corps, Air Force, 
Space Force, Coast Guard, Public Health Service, or Bureau of Prisons 
who are authorized to prescribe via telemedicine in the course of their 
official duties;
    (2) Veterans Health Administration (VHA) covered health care 
professionals under 38 U.S.C. 1730C(b), acting within the scope of 
their employment who are utilizing the registration of a hospital or 
clinic operated by the VHA registered under 21 U.S.C. 823(g) after 
having obtained the approval of the Secretary of the Veterans Affairs 
(VA) to utilize the 823(g) registration of a VHA-operated hospital or 
clinic; and
    (3) Health care professionals acting within the scope of their 
contract with VHA and who have access to, and chart patient records 
within, the VHA's electronic health records, are subject to all 
policies of the VHA, and are utilizing the registration of a hospital 
or clinic operated by the VHA registered under 21 U.S.C. 823(g) after 
having obtained the approval of the Secretary of the Veterans Affairs 
(VA) to utilize the 823(g) registration of a VA-operated hospital or 
clinic; and
    (4) Any practitioner otherwise exempted from registration under 21 
U.S.C. 822(d).
0
6. In Sec.  1301.13, add paragraphs (e)(1)(xi), (xii), (xiii), (xiv), 
and (xv), (k), (l) to read as follows:


Sec.  1301.13  Application for registration; time for application; 
expiration date; registration for independent activities; application 
forms, fees, contents and signature; coincident activities.

* * * * *
    (e) * * *
    (1)

[[Page 6595]]



 
----------------------------------------------------------------------------------------------------------------
                                                                                                    Coincident
      Business activity           Controlled    DEA application    Application    Registration      activities
                                  substances         forms          fees ($)     period (years)      allowed
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
(xi) Telemedicine Prescribing  Schedules III-V  New--224S                   888               3
 (Special Registration).                         Renewal--224S
                                                 Modification--
                                                 224S(M).
(xii) Advanced Telemedicine    Schedules II-V.  New--224S                   888               3
 Prescribing (Special                            Renewal--224S
 Registration).                                  Modification--
                                                 224S(M).
(xiii) Telemedicine Platform   Schedules II-V.  New--224S                   888               3
 (Special Registration).                         Renewal--224S
                                                 Modification--
                                                 224S(M).
(xiv) State Telemedicine for   (Determined by   New--224S                    50               3
 Individual Special             the Special      Renewal--224S
 Registrants (Ancillary         Registration     Modification--
 Registration to a Special      held).           224S(M).
 Registration).
(xv) State Telemedicine for    (Determined by   New--224S                   888               3
 Platform Special Registrants   the Special      Renewal--224S
 (Ancillary Registration to a   Registration     Modification--
 Special Registration).         held).           224S(M).
----------------------------------------------------------------------------------------------------------------

* * * * *
    (k) Special Registration application (Form 224S) requirements. Form 
224S will require the following:
    (1) Special registered location. Special Registration applicants 
shall designate one of their existing registered locations under 
paragraph (e)(1)(iv) of this section as the registered location/
physical address of their Special Registration. Special Registration 
applicants that would be exempted under Sec.  1301.11(d) are exempted 
from this requirement however, such exempted persons shall be required 
to provide another physical address.
    (2) Required disclosures and attestations. Special Registration 
applicants shall provide the following specific disclosures and 
attestations on the Form 224S:
    (i) If the applicant is a platform practitioner applying for the 
Telemedicine Platform Registration, it shall disclose all employment, 
contractual relationships, or professional affiliations with any 
clinician special registrant and Online Pharmacy and their respective 
registration numbers.
    (ii) If the applicant is a clinician practitioner applying for the 
Telemedicine Prescribing Registration or the Advanced Telemedicine 
Prescribing Registration, the applicant shall disclose all employment, 
contractual relationships, or professional affiliations, including with 
any covered online telemedicine platform and the respective covered 
online telemedicine platform's Telemedicine Platform Special 
Registration number, if applicable; and the applicant's practice 
specialties (e.g., hospice care or palliative care);
    (iii) The applicant for a Special Registration for Telemedicine, 
whether a clinician practitioner or a covered online telemedicine 
platform, shall attest that they have devised and are committed to 
maintaining anti-diversion policies and procedures;
    (iv) The applicant for an Advanced Telemedicine Prescribing 
Registration shall disclose their practice specialties; and
    (v) The applicant for any type of Special Registration for 
Telemedicine shall attest that they have a legitimate need for a 
Special Registration for Telemedicine and to the facts and 
circumstances that form the basis for their legitimate need.
    (3) State Telemedicine Registration-exempted practitioner 
disclosures. Practitioners exempted from State Telemedicine 
Registration under Sec.  1301.11(d) are required to identify all the 
states in which patients will be located when being treated via 
telemedicine on the practitioners' registration applications for the 
Telemedicine Prescribing Registration, the Advanced Telemedicine 
Prescribing Registration, and the Telemedicine Platform Registration.
    (l) Notification of application changes; Modifications (Form 224S-
M). The special registrant shall use Form 224S-M for the following 
purposes:
    (1) To promptly notify DEA of any changes to the information 
provided on their Special Registration Application (Form 224S) within 
14 business days on the Form 224S-M (e.g., the special registrant 
becomes employed by, contracts with, or otherwise professionally 
affiliated with a new entity); and
    (2) To make any modifications to their Special Registration (e.g., 
applying for additional State Telemedicine Registrations to practice 
telemedicine in additional states).
0
7. In Sec.  1301.35, revise paragraph (a) and add paragraph (d) to read 
as follows:


Sec.  1301.35  Certificate of registration; denial of registration.

    (a) The Administrator shall issue a Certificate of Registration 
(DEA Form 223) to an applicant under the applicable provisions of 
sections 102(54)(E) or 311(h) of the Act (21 U.S.C. 802(54)(E) and 
831(h)) when:
    (1) The applicant for the Special Registration for Telemedicine 
meets the eligibility requirements outlined in Sec.  1301.11(c) of this 
subpart; and
    (2) The Administrator has determined that the Special Registration 
is consistent with the public interest pursuant to the factors 
stipulated in 21 U.S.C. 823(g)(1).
* * * * *
    (d) The Certificate of Registration (DEA Form 223) issued for a 
Special Registration shall contain the following information: name; 
Special Registered Location; Special Registration for Telemedicine 
(either a Telemedicine Prescribing Registration, Advanced Telemedicine 
Prescribing Registration, or Telemedicine Platform Registration), and 
State Telemedicine Registration(s);

[[Page 6596]]

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. The special registrant shall maintain the Certificate of 
Registration at the Special Registered Location in a readily 
retrievable manner and shall permit inspection of the certificate by 
any official, agent or employee of the Administration or of any 
Federal, State, or local agency engaged in enforcement of laws relating 
to controlled substances.
0
8. In Sec.  1301.36:
0
a. Redesignate paragraphs (c) through (i) as paragraphs (d) through 
(j), respectively; and
0
b. Add paragraphs (c) and (k).
    The additions read as follows:


Sec.  1301.36  Suspension or revocation of registration; suspension of 
registration pending final order; extension of registration pending 
final order.

* * * * *
    (c) For any registration issued under sections 102(54)(E) or 311(h) 
of the Act (21 U.S.C. 802(54)(E) and 831(h)), the Administrator may:
    (1) Suspend the registration under the grounds stipulated in 
section 304(a) of the Act (21 U.S.C. 824(a)) for any period of time; 
and
    (2) Revoke the registration under the grounds stipulated in section 
304(a) of the Act (21 U.S.C. 824(a)).
* * * * *
    (k) The suspension or revocation of any registration issued under 
21 U.S.C. 823(g) shall result in the automatic suspension or revocation 
of all registrations issued under 21 U.S.C. 831(h), including all 
Special Registrations for Telemedicine and State Telemedicine 
Registrations.

PART 1304--RECORDS AND REPORTS OF REGISTRANTS

0
9. The authority citation for part 1304 continues to read as follows:

    Authority:  21 U.S.C. 821, 827, 831, 871(b), 958(e)-(g), and 
965, unless otherwise noted.

0
10. In Sec.  1304.04, add paragraphs (i), (j), (k), and (l) to read as 
follows:


Sec.  1304.04  Maintenance of records and inventories.

* * * * *
    (i) For patient verification photographic records, an individual 
special registrant, with a Special Registration for Telemedicine 
pursuant to 1301.11(c)(2) or (3) of this chapter, or a delegated 
employee or contractor under the direct supervision of the individual 
special registrant, shall verify the identity of patients prior to 
issuing a special registration prescription via an audio-video 
telecommunications system, as defined under Sec.  1300.04 of this 
chapter. At the first telemedicine encounter, the individual special 
registrant, or a delegated employee or contractor under the direct 
supervision of the individual special registrant, shall confirm the 
identity of the patient, and capture a photographic record of the 
patient presenting their federal or state-issued photo identification 
card or other acceptable documents as described in paragraph (i)(1) of 
this section; or verify, accept and maintain a copy of the patient's 
federal or state government-issued photo identification card or a 
document described in paragraph (i)(1) of this section provided by the 
patient. The photographic record shall be maintained by the individual 
special registrant and renewed a minimum of every two (2) years. After 
the first telemedicine encounter, the individual special registrant, or 
the individual special registrant's delegee, shall confirm the 
patient's identity against the initial or renewed photographic record 
at every telemedicine encounter that results in a special telemedicine 
prescription.
    (1) If the individual special registrant or a delegated employee or 
contractor under the direct supervision of the individual special 
registrant reasonably determines that a patient lacks a federal or 
state-issued photo identification card, the individual special 
registrant or their delegee must verify the identity of the patients in 
the manner described in this paragraph (i) using other forms of 
documentation to verify the identity of the patient, and maintain a 
photographic record of what documents were used to verify the patient's 
identity.
    (2) The photographic records must be securely stored within the 
patient's medical record or chart, separate from the special 
registration prescription data reported to DEA under Sec.  1304.60 of 
this subpart to ensure that patient privacy is protected.
    (j) For the purpose of maintaining special registration 
telemedicine encounter record, every telemedicine encounter that 
results in a special registration prescription, the prescribing 
individual special registrant shall 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. The 
individual special registrant must maintain the special registration 
telemedicine encounter record for a minimum of two (2) years from the 
date of the telemedicine encounter.
    (k) For credential verification and conduct-related records, a 
platform special registrant, with a Special Registration for 
Telemedicine pursuant to 1301.11(c)(4) of this chapter, shall maintain 
the following records related to individual special registrants with 
whom they enter and maintain a covered platform relationship:
    (1) Verification of the individual practitioner's credentials, 
including but not limited to records on education, training, board or 
specialty certifications;
    (2) The employment contract and any other contract between the 
platform practitioner and the individual practitioner; and
    (3) Any disciplinary actions or sanctions, or documentation of 
complaints, disputes, or incidents involving the practice of 
telemedicine engaged in by the individual practitioner. The platform 
practitioner must maintain and update the credential verification and 
conduct-related records for a minimum of two (2) years.
    (l) For the purpose of maintaining centralized recordkeeping at the 
special registered location, a special registrant, with a Special 
Registration for Telemedicine pursuant to 1301.11(c)(2)-(4) shall 
maintain all records arising from telemedicine encounters at the 
special registrant's Special Registered Location.
0
10. Add Sec.  1304.60 under the undesignated center heading 
``Prescription Reporting'' to read as follows:


Sec.  1304.60  Pharmacy reporting of special registration prescription 
data.

    (a) A pharmacy shall, within seven (7) days of the start of every 
month, report aggregate data for the special registration prescriptions 
filled during the preceding month for each Schedule II controlled 
substance and each Schedule III-V controlled substance identified in 
paragraph (b). For each of these controlled substances, the pharmacy 
shall 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

[[Page 6597]]

patients prescribed the controlled substance. If the individual special 
registrant is exempted from State Telemedicine Registration under Sec.  
1301.11(d) of this chapter, the pharmacy shall instead provide the 
Special Registration number for either the Telemedicine Prescribing 
Registration or Advanced Telemedicine Prescribing Registration of the 
individual special registrant in lieu of a State Telemedicine 
Registration number. The pharmacy shall electronically report this data 
through DEA Office of Diversion Control's secure network application.
    (b) The Schedule III-V controlled substances subject to the 
reporting requirement in paragraph (a) of this section are:
    (1) Ketamine, its salts, isomers, and salts of isomers (DEA 
Controlled Substances Code Number (CSCN) 7285);
    (2) 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol, its 
salts, optical and geometric isomers and salts of these isomers 
(including tramadol) (CSCN 9752); and
    (3) The following depressants as described in 1308.14(c) of this 
chapter, and their salts, isomers, and salt of isomers: Alprazolam 
(CSCN 2882); Bromazepam (CSCN 2748); Camazepam (CSCN 2749; 
Chlordiazepxide (CSCN 2744); Clobazam (CSCN 2751); Clonazepam (CSCN 
2737); Clorazepate (CSCN 2768); Clotiazepam (CSCN 2752); Cloxazolam 
(CSCN 2753); Delorazepam (CSCN 2754); Diazepam (CSCN 2765); Estazolam 
(CSCN 2756); Ethyl loflazepate (CSCN 2758); Fludiazepam (CSCN 2759); 
Flunitrazepam (CSCN 2763); Flurazepam (CSCN 2767); Halazepam (CSCN 
2762); Haloxazolam (CSCN 2771); Ketazolam (CSCN 2772); Loprazolam (CSCN 
2773); Lorazepam (CSCN 2885); Lormetazepam (CSCN 2774); Medazepam (CSCN 
2836); Midazolam (CSCN 2884); Nimetazepam (CSCN 2837); Nitrazepam (CSCN 
2834); Nordiazepam (CSCN 2838); Oxazepam (CSCN 2835); Oxazolam (CSCN 
2839); Pinazepam (CSCN 2883); Prazepam (CSCN 2764); Quazepam (CSCN 
2881); Remimazolam (CSCN 2846); Temazepam (CSCN 2925); Tetrazepam (CSCN 
2886); and Triazolam (CSCN 2887).
0
12. Add Sec.  1304.61 to read as follows:


Sec.  1304.61  Special registrant reporting of special registration 
prescription data.

    A special registrant, either an individual special registrant or a 
platform special registrant, shall report to DEA on an annual basis 
within the seven (7) days of the start of every year the following 
information for the preceding year: the total number of new patients in 
each state where at least one special registration prescription for a 
Schedule II controlled substance, or a Schedule III-V controlled 
substance identified in Sec.  1304.60(b) has been issued; 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 Schedule III-V controlled substances identified in Sec.  1304.60(b) 
issued by the special registrant, in aggregate and across all states. 
The individual special registrant shall electronically report this data 
through DEA Office of Diversion Control's secure network application.

PART 1306--PRESCRIPTIONS AND DISPENSING

0
14. The authority citation for part 1306 continues to read as follows:

    Authority:  21 U.S.C. 821, 829, 831, 871(b), unless otherwise 
noted.

0
15. Add an undesignated center heading ``Special Registration 
Prescriptions Prescribed by Individual Special Registrants'' and 
Sec. Sec.  1306.41 through 1306.47 to read as follows:

Special Registration Prescriptions Prescribed by Individual Special 
Registrants


Sec.  1306.41  Prescription origination within the United States.

    The individual special registrant shall be physically located 
within the United States when conducting a telemedicine encounter and 
issuing a special registration prescription; and have any necessary 
licensure and authorization within the U.S. state or territory where 
the practitioner is located when the telemedicine encounter takes 
place. For the purposes of this chapter, the United States shall mean 
the 50 states of the United States of America, the District of 
Columbia, the Commonwealth of Puerto Rico, Guam, the U.S. Virgin 
Islands, America Samoa, Wake Island, Midway Islands, Kingman Reef, 
Johnston Atoll, the Northern Mariana Islands, and any other trust 
territory or possession of the United States.


Sec.  1306.42  Electronic Prescribing for Controlled Substances (EPCS) 
of Special Registration Prescriptions.

    The individual special registrant shall issue special registration 
prescriptions for controlled substances through Electronic Prescribing 
for Controlled Substances (EPCS).


Sec.  1306.43  Nationwide Prescription Drug Monitoring Program (PDMP) 
Check

    (a) Effective immediately, on [EFFECTIVE DATE OF FINAL RULE], prior 
to issuing a special registration prescription for controlled 
substances, including Schedules II through V controlled substances, the 
individual special registrant shall perform a check of the state 
Prescription Drug Monitoring Program(s) (PDMPS) in:
    (1) The state or territory where the patient is located;
    (2) The state or territory where the individual special registrant 
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 individual special registrant is located, for 
data regarding any controlled substance prescriptions issued to the 
patient in the last year, or, if less than one year of data is 
available, in the entire available period, prior to issuing a special 
registration prescription for controlled substances.
    (b) Effective three (3) years from [EFFECTIVE DATE OF FINAL RULE], 
the individual special registrant shall perform a comprehensive 
nationwide check of all 50 state Prescription Drug Monitoring Programs 
(PDMPs) and PDMPs in any U.S. district and territory that maintains its 
own PDMP for data regarding any controlled substance prescriptions 
issued to the patient in the last year, or, if less than one year of 
data is available, in the entire available period, prior to issuing a 
special registration prescription for controlled substances. If there 
is no means to perform this comprehensive nationwide check three (3) 
years from [the date of the promulgation of the final rule], then the 
individual special registrant shall continue to perform the PDMPs 
checks as described in paragraph (a) if this section, and special 
registration prescriptions for Schedule II controlled substances shall 
only be issued to patients located within the same state as the 
individual special registrant, i.e., where there is an intra-state 
practitioner-patient relationship.


Sec.  1306.44  Required Use of Audio-Video Telecommunication System

    (a) Every special registration prescription, as defined in Sec.  
1300.04 of this chapter, shall be issued through the use of an audio-
video telecommunication system defined in Sec.  1300.04 of this 
chapter.
    (b) Notwithstanding paragraph (a) of this section and Sec.  1300.04 
of this chapter, special registrants may issue special registration 
prescriptions for

[[Page 6598]]

Schedule III-V narcotic controlled substances approved by the Food and 
Drug Administration for the treatment of Opioid Use Disorder 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 Sec.  
1300.04 of this chapter, the practitioner has conducted at least one 
medical evaluation of the patient through the use of an audio-video 
telecommunication system defined in Sec.  1300.04 of this chapter, and 
the prescription is being issued for the treatment of Opioid Use 
Disorder.


Sec.  1306.45  Requirements for Issuing a Special Registration 
Prescription for Schedule II Controlled Substances

    (a) A special registration prescription may not be issued for a 
controlled substance listed in Schedule II unless the individual 
special registrant has an Advanced Telemedicine Prescribing 
Registration and the individual special registrant is: a psychiatrist 
or board certified in the treatment of psychiatric and psychological 
disorders, and issuing the prescription for the treatment of mental 
health; a hospice care physician or board certified in hospice care, 
and issuing the prescription for hospice care; a palliative care 
physician or board certified in palliative care, and issuing the 
prescription for palliative care; a physician rendering treatment to a 
patient who resides and is present in a long term care facility at the 
time the prescription is issued; a pediatrician or board certified in 
pediatric care, and is issuing the prescription to a patient under the 
age of 18 while the parent or guardian of the patient is present in the 
room with the patient at the time the prescription is issued; or a 
neurologist or board certified in the treatment of neurological 
disorders unrelated to the treatment and management of pain
    (b) A special registration prescription may not be issued for a 
controlled substance listed in Schedule II unless the individual 
special registrant is physically located in the same state in which the 
patient was located at the time of the telemedicine encounter that 
resulted in the issuance of the prescription when issuing the 
prescription for the Schedule II controlled substance.
    (c) The number of special registration prescriptions issued by the 
individual special registrant in a calendar month for Schedule II 
controlled substances shall constitute less than 50 percent of the 
total number of Schedule II prescriptions issued in that calendar month 
by the individual special registrant in their telemedicine and non-
telemedicine practice. The average number of special registration 
prescriptions shall be calculated from the first day of the month 
through the last day of the month.


Sec.  1306.46  State Laws Applicable to Special Registration 
Prescriptions

    When issuing a special registration prescription, a special 
registrant must comply with the laws and regulations of:
    (a) The state in which the special registrant is located during the 
telemedicine encounter resulting in the special registration 
prescription;
    (b) The state in which the patient is located during the 
telemedicine encounter resulting in the special registration 
prescription; and
    (c) 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 described in paragraphs (a) and (b) of this section.


Sec.  1306.47  Additional Elements on a Special Registration 
Prescription

    (a) A special registration prescription shall contain: the 
individual special registrant's Special Registration for Telemedicine 
number and State Telemedicine Registration number, unless exempted from 
State Telemedicine Registration under Sec.  1301.11(d) of this chapter; 
and, if the prescription is facilitated by a platform registrant, the 
covered online telemedicine platform's Special Registration for 
Telemedicine number and State Telemedicine Registration number. If 
exempted from State Telemedicine Registration, the special registrant 
shall notate on the prescription the state in which the patient was 
located at the time of the telemedicine encounter that resulted in the 
issuance of the prescription.
    (b) A special registration prescription shall contain all the 
information required on a prescription under Sec.  1306.05(a) of this 
chapter, with the exception that the number associated with a 
registration under 1301.13(e)(1)(iv) of this chapter shall not be 
required.
    (c) A corresponding liability rests upon the pharmacist who fills a 
special registration prescription that is not prepared in the form 
required by this regulation.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
January 13, 2025, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-01099 Filed 1-15-25; 8:45 am]
BILLING CODE 4410-09-P`